Budesonide    (DrugBank: Budesonide)

9 diseases
告示番号疾患名(ページ内リンク)臨床試験数
66IgA腎症21
93原発性胆汁性胆管炎15
94原発性硬化性胆管炎1
95自己免疫性肝炎2
96クローン病27
97潰瘍性大腸炎50
98好酸球性消化管疾患34
228閉塞性細気管支炎2
299嚢胞性線維症1

66. IgA腎症 [臨床試験数:199,薬物数:214(DrugBank:57),標的遺伝子数:32,標的パスウェイ数:128
Searched query = "IgA nephropathy", "IgA nephritis", "Berger disease", "IgA-IgG nephropathy"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
21 / 199 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-003308-14-GR
(EUCTR)
03/12/202026/10/2020Study in which Efficacy and Safety of Nefecon is Evaluated in Patients With IgA Nepropathy Who Have Completed Study Nef-301An Open-Label Extension (OLE) Study to Evaluate the Efficacy and Safety of Nefecon Treatment in Patients With IgA Nephropathy Who Have Completed Study Nef-301 Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
Product Code: Nefecon
INN or Proposed INN: BUDESONIDE
Calliditas Therapeutics ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3United States;Belarus;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Belgium;Poland;Australia;Germany;Sweden;Korea, Republic of
2EUCTR2020-003308-14-PL
(EUCTR)
24/11/202001/10/2020Study in which Efficacy and Safety of Nefecon is Evaluated in Patients With IgA Nepropathy Who Have Completed Study Nef-301An Open-Label Extension (OLE) Study to Evaluate the Efficacy and Safety of Nefecon Treatment in Patients With IgA Nephropathy Who Have Completed Study Nef-301 Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
Product Code: Nefecon
INN or Proposed INN: BUDESONIDE
Calliditas Therapeutics ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3United States;Belarus;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;Sweden;Korea, Republic of
3EUCTR2020-003308-14-FR
(EUCTR)
13/11/202013/10/2020Study in which Efficacy and Safety of Nefecon is Evaluated in Patients With IgA Nepropathy Who Have Completed Study Nef-301An Open-Label Extension (OLE) Study to Evaluate the Efficacy and Safety of Nefecon Treatment in Patients With IgA Nephropathy Who Have Completed Study Nef-301 Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
Product Code: Nefecon
INN or Proposed INN: BUDESONIDE
Calliditas Therapeutics ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3United States;Belarus;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Belgium;Poland;Australia;Germany;Sweden;Korea, Republic of
4EUCTR2020-003308-14-GB
(EUCTR)
12/11/202021/10/2020Study in which Efficacy and Safety of Nefecon is Evaluated in Patients With IgA Nepropathy Who Have Completed Study Nef-301An Open-Label Extension (OLE) Study to Evaluate the Efficacy and Safety of Nefecon Treatment in Patients With IgA Nephropathy Who Have Completed Study Nef-301 Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
Product Code: Nefecon
INN or Proposed INN: BUDESONIDE
Calliditas Therapeutics ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3United States;Belarus;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;Sweden;Korea, Republic of
5EUCTR2020-003308-14-CZ
(EUCTR)
21/10/202016/09/2020Study in which Efficacy and Safety of Nefecon is Evaluated in Patients With IgA Nepropathy Who Have Completed Study Nef-301An Open-Label Extension (OLE) Study to Evaluate the Efficacy and Safety of Nefecon Treatment in Patients With IgA Nephropathy Who Have Completed Study Nef-301 Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
Product Code: Nefecon
INN or Proposed INN: BUDESONIDE
Calliditas Therapeutics ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3United States;Belarus;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Belgium;Poland;Australia;Germany;Sweden;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2020-003308-14-SE
(EUCTR)
21/10/202018/09/2020Study in which Efficacy and Safety of Nefecon is Evaluated in Patients With IgA Nepropathy Who Have Completed Study Nef-301An Open-Label Extension (OLE) Study to Evaluate the Efficacy and Safety of Nefecon Treatment in Patients With IgA Nephropathy Who Have Completed Study Nef-301 Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
Product Code: Nefecon
INN or Proposed INN: BUDESONIDE
Calliditas Therapeutics ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3United States;Belarus;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;Sweden;Korea, Republic of
7EUCTR2017-004902-16-FI
(EUCTR)
18/07/201802/03/2018A study in which the safety and efficacy of Nefecon is compared with placebo in patients with primary IgA Nephropathy.A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients with Primary IgA Nephropathy at Risk of Progressing to End-Stage Renal Disease (NefIgArd). Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
Product Code: Nefecon
INN or Proposed INN: BUDESONIDE
Other descriptive name: Nefecon
Calliditas Therapeutics ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 3United States;Belarus;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;China;Sweden;Korea, Republic of
8EUCTR2017-004902-16-CZ
(EUCTR)
04/06/201812/02/2018A study in which the safety and efficacy of Nefecon is compared with placebo in patients with primary IgA Nephropathy.A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients with Primary IgA Nephropathy at Risk of Progressing to End-Stage Renal Disease (NefIgArd). Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
Product Code: Nefecon
INN or Proposed INN: BUDESONIDE
Other descriptive name: Nefecon
Calliditas Therapeutics ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 3United States;Belarus;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;China;Sweden;Korea, Republic of
9EUCTR2017-004902-16-GB
(EUCTR)
29/05/201822/06/2018A study in which the safety and efficacy of Nefecon is compared with placebo in patients with primary IgA Nephropathy.A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients with Primary IgA Nephropathy at Risk of Progressing to End-Stage Renal Disease (NefIgArd). Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
Product Code: Nefecon
INN or Proposed INN: BUDESONIDE
Other descriptive name: Nefecon
Calliditas Therapeutics ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 3United States;Belarus;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;China;Sweden;Korea, Republic of
10EUCTR2017-004902-16-ES
(EUCTR)
09/04/201802/03/2018A study in which the safety and efficacy of Nefecon is compared with placebo in patients with primary IgA Nephropathy.A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients with Primary IgA Nephropathy at Risk of Progressing to End-Stage Renal Disease (NefIgArd). Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
Product Code: Nefecon
INN or Proposed INN: BUDESONIDE
Other descriptive name: Nefecon
Calliditas Therapeutics ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Belarus;Taiwan;Greece;Finland;Spain;Turkey;Italy;United Kingdom;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;Korea, Republic of;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2017-004902-16-SE
(EUCTR)
28/03/201813/02/2018A study in which the safety and efficacy of Nefecon is compared with placebo in patients with primary IgA Nephropathy.A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients with Primary IgA Nephropathy at Risk of Progressing to End-Stage Renal Disease (NefIgArd). Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 20.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
Product Code: Nefecon
INN or Proposed INN: BUDESONIDE
Other descriptive name: Nefecon
Calliditas Therapeutics ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 3United States;Belarus;Taiwan;Greece;Finland;Spain;Turkey;United Kingdom;Italy;France;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;China;Korea, Republic of;Sweden
12EUCTR2012-001923-11-ES
(EUCTR)
09/01/201329/11/2012A study to assess if two different doses of Nefecon taken as capsules are safe and effective in patients with primary IgA nephropathy at risk of developing end-stage renal diseaseA Multicentre, Interventional Treatment, Randomised, Double-Blind, Single Group Assignment, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon® in Primary IgA Nephropathy Patients at Risk of Developing End-Stage Renal Disease - The NEFIGAN Trial Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 14.1;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
INN or Proposed INN: BUDESONIDE
Pharmalink ABNULLNot RecruitingFemale: yes
Male: yes
200Czech Republic;Finland;Belgium;Spain;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
13EUCTR2012-001923-11-NL
(EUCTR)
18/12/201219/10/2012A study to assess if two different doses of Nefecon taken as capsules are safe and effective in patients with primary IgA nephropathy at risk of developing end-stage renal diseaseA Multicentre, Interventional Treatment, Randomised, Double-Blind, Single Group Assignment, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon® in Primary IgA Nephropathy Patients at Risk of Developing End-Stage Renal Disease - The NEFIGAN Trial Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 16.0;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
INN or Proposed INN: BUDESONIDE
Pharmalink ABNULLNot RecruitingFemale: yes
Male: yes
200Czech Republic;Finland;Spain;Belgium;Denmark;Germany;Netherlands;United Kingdom;Italy;Sweden
14EUCTR2012-001923-11-SE
(EUCTR)
21/11/201203/09/2012A study to assess if two different doses of Nefecon taken as capsules are safe and effective in patients with primary IgA nephropathy at risk of developing end-stage renal diseaseA Multicentre, Interventional Treatment, Randomised, Double-Blind, Single Group Assignment, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon® in Primary IgA Nephropathy Patients at Risk of Developing End-Stage Renal Disease - The NEFIGAN Trial Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 17.1;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
INN or Proposed INN: BUDESONIDE
Pharmalink ABNULLNot RecruitingFemale: yes
Male: yes
200Czech Republic;Finland;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
15EUCTR2012-001923-11-BE
(EUCTR)
19/11/201222/08/2012A study to assess if two different doses of Nefecon taken as capsules are safe and effective in patients with primary IgA nephropathy at risk of developing end-stage renal diseaseA Multicentre, Interventional Treatment, Randomised, Double-Blind, Single Group Assignment, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon® in Primary IgA Nephropathy Patients at Risk of Developing End-Stage Renal Disease - The NEFIGAN Trial Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 17.1;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
INN or Proposed INN: BUDESONIDE
Pharmalink ABNULLNot RecruitingFemale: yes
Male: yes
200Phase 2Czech Republic;Finland;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2012-001923-11-GB
(EUCTR)
06/11/201228/09/2012A study to assess if two different doses of Nefecon taken as capsules are safe and effective in patients with primary IgA nephropathy at risk of developing end-stage renal diseaseA Multicentre, Interventional Treatment, Randomised, Double-Blind, Single Group Assignment, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon® in Primary IgA Nephropathy Patients at Risk of Developing End-Stage Renal Disease - The NEFIGAN Trial Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 17.1;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
INN or Proposed INN: BUDESONIDE
Pharmalink ABNULLNot RecruitingFemale: yes
Male: yes
200Czech Republic;Finland;Belgium;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden
17EUCTR2012-001923-11-DK
(EUCTR)
05/11/201214/09/2012A study to assess if two different doses of Nefecon taken as capsules are safe and effective in patients with primary IgA nephropathy at risk of developing end-stage renal diseaseA Multicentre, Interventional Treatment, Randomised, Double-Blind, Single Group Assignment, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon® in Primary IgA Nephropathy Patients at Risk of Developing End-Stage Renal Disease - The NEFIGAN Trial Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 17.1;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
INN or Proposed INN: BUDESONIDE
Pharmalink ABNULLNot RecruitingFemale: yes
Male: yes
200Phase 2Czech Republic;Finland;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
18EUCTR2012-001923-11-CZ
(EUCTR)
24/10/201216/08/2012A study to assess if two different doses of Nefecon taken as capsules are safe and effective in patients with primary IgA nephropathy at risk of developing end-stage renal diseaseA Multicentre, Interventional Treatment, Randomised, Double-Blind, Single Group Assignment, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon® in Primary IgA Nephropathy Patients at Risk of Developing End-Stage Renal Disease - The NEFIGAN Trial Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 17.1;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
INN or Proposed INN: BUDESONIDE
Pharmalink ABNULLNot RecruitingFemale: yes
Male: yes
200Phase 2Czech Republic;Finland;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
19EUCTR2012-001923-11-FI
(EUCTR)
17/10/201215/08/2012A study to assess if two different doses of Nefecon (budesonide) compared to placebo are safe and effective in patients with primary IgA nephropathy at risk of developing end-stage renal diseaseA Multicentre, Interventional Treatment, Randomised, Double-Blind, Single Group Assignment, Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon® in Primary IgA Nephropathy Patients at Risk of Developing End-Stage Renal Disease - The NEFIGAN Trial Primary IgA nephropathy patients at risk of developing end stage renal disease
MedDRA version: 17.1;Level: LLT;Classification code 10069341;Term: Berger's disease;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
INN or Proposed INN: BUDESONIDE
Pharmalink ABNULLNot RecruitingFemale: yes
Male: yes
200Czech Republic;Finland;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
20EUCTR2012-001923-11-IT
(EUCTR)
27/09/201224/09/2012A study to assess if two different doses of Nefecon taken as a capsule are safe and effective in patients with primary IgA nephropathy at risk of developing end-stage renal diseaseA Multicentre, Interventional treatment, Randomised, Double-Blind, Single Group Assignment Placebo Controlled Study to Evaluate the Efficacy and Safety of Two Different Doses of Nefecon in primary IgA nephropathy patients at risk of developing end-stage renal disease - NEFIGAN Trial Primary IgA nephropathy at risk of developing end stage renal disease
MedDRA version: 15.0;Level: LLT;Classification code 10037034;Term: Proteinuria present;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Nefecon
Product Code: A07EA06
INN or Proposed INN: BUDESONIDE
CROWN OYNULLNot RecruitingFemale: yes
Male: yes
200Czech Republic;Finland;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT00767221
(ClinicalTrials.gov)
October 20055/10/2008Oral Treatment With PL-56 in Patients With IgA Nephropathy - an Explorative StudyOral Treatment With PL-56 in Patients With IgA Nephropathy - an Explorative StudyIGA NephropathyDrug: BudesonidePharmalink ABArchimedes Development LtdCompleted18 YearsN/ABoth20Phase 2Sweden

93. 原発性胆汁性胆管炎 [臨床試験数:230,薬物数:215(DrugBank:51),標的遺伝子数:34,標的パスウェイ数:107
Searched query = "Primary biliary cholangitis", "Primary biliary cirrhosis", "PBC"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
15 / 230 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2007-004040-70-PL
(EUCTR)
30/04/201320/03/2013Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosisDouble-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflammatory activity in the histological assessment of the liver
MedDRA version: 17.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Ursofalk
INN or Proposed INN: URSODEOXYCHOLIC ACID
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
144Phase 3Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Netherlands;Germany;Sweden
2EUCTR2007-004040-70-GB
(EUCTR)
01/06/200919/08/2008Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBCDouble-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC Patients with Primary Biliary Cirrhosis at risk of disease progression
MedDRA version: 9.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Ursofalk
INN or Proposed INN: URSODEOXYCHOLIC ACID
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
183Phase 3Finland;Spain;Lithuania;Austria;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden
3EUCTR2007-004040-70-IT
(EUCTR)
20/05/200922/05/2009Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBCDouble-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC Patients with PBC and with risk of a progression of this disease.
MedDRA version: 9.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis
Trade Name: Budesonide
INN or Proposed INN: Budesonide
Trade Name: acido ursodessicolico
INN or Proposed INN: Ursodeoxycholic acid
DR. FALK PHARMA GMBHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
183Phase 3Hungary;Finland;United Kingdom;Germany;Netherlands;Denmark;France;Spain;Italy;Austria;Lithuania;Sweden
4EUCTR2007-004040-70-AT
(EUCTR)
19/03/200923/06/2008Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBCDouble-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC Patients with Primary Biliary Cirrhosis at risk of disease progression
MedDRA version: 9.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Ursofalk
INN or Proposed INN: URSODEOXYCHOLIC ACID
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
183Phase 3Finland;Spain;Lithuania;Austria;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden
5NCT00746486
(ClinicalTrials.gov)
February 20093/9/2008Ursodeoxycholic Acid Plus Budesonide Versus Ursodeoxycholic Acid Alone in Primary Biliary Cirrhosis (PBC)Double-blind, Randomised, Placebo-controlled, Multi-centre Phase III Clinical Study Comparing the Combination of Ursodeoxycholic Acid Capsules Plus Budesonide Capsules to Ursodeoxycholic Acid Capsules Plus Placebo in the Treatment of Primary Biliary CirrhosisPrimary Biliary CirrhosisDrug: budesonide;Drug: budesonide placeboDr. Falk Pharma GmbHNULLTerminated18 YearsN/AAll62Phase 3France;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2007-004040-70-DK
(EUCTR)
29/01/200919/11/2008Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosisDouble-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflammatory activity in the histological assessment of the liver
MedDRA version: 16.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Ursofalk
INN or Proposed INN: URSODEOXYCHOLIC ACID
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
144Phase 3Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden
7EUCTR2007-004040-70-LT
(EUCTR)
22/12/200816/09/2008Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosisDouble-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflammatory activity in the histological assessment of the liver
MedDRA version: 18.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Ursofalk
INN or Proposed INN: URSODEOXYCHOLIC ACID
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
144Phase 3Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden
8EUCTR2007-004040-70-FI
(EUCTR)
10/11/200825/06/2008Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosisDouble-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflammatory activity in the histological assessment of the liver
MedDRA version: 17.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Ursofalk
INN or Proposed INN: URSODEOXYCHOLIC ACID
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
144Phase 3Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden
9EUCTR2007-004040-70-HU
(EUCTR)
18/10/200804/08/2008Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosisDouble-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflammatory activity in the histological assessment of the liver
MedDRA version: 14.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Ursofalk
INN or Proposed INN: URSODEOXYCHOLIC ACID
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
144Phase 3Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden
10EUCTR2007-004040-70-ES
(EUCTR)
01/10/200801/08/2008Estudio aleatorizado, doble ciego, controlado con placebo, multicéntrico, de fase III, de grupos paralelos, para comparar la combinación de capsulas de ácido ursodeoxicólico y capsulas de budesonida con la combinación de capsulas de ácido ursodeoxicólico y capsulas placebo en el tratamiento de la cirrosis biliar primaria(Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis) - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBCEstudio aleatorizado, doble ciego, controlado con placebo, multicéntrico, de fase III, de grupos paralelos, para comparar la combinación de capsulas de ácido ursodeoxicólico y capsulas de budesonida con la combinación de capsulas de ácido ursodeoxicólico y capsulas placebo en el tratamiento de la cirrosis biliar primaria(Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis) - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC Pacientes con cirrosis biliar primaria con riesgo de progresíon de la enfermedadPatients with Primary Biliary Cirrhosis at risk of disease progression
MedDRA version: 9.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Ursofalk
INN or Proposed INN: URSODEOXYCHOLIC ACID
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
183Phase 3Finland;Spain;Lithuania;Austria;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2007-004040-70-SE
(EUCTR)
22/09/200802/06/2008Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosisDouble-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflammatory activity in the histological assessment of the liver
MedDRA version: 17.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Ursofalk
INN or Proposed INN: URSODEOXYCHOLIC ACID
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
144Phase 3Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden
12EUCTR2007-004040-70-FR
(EUCTR)
09/09/200809/06/2008Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBCDouble-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC Patients with Primary Biliary Cirrhosis at risk of disease progression
MedDRA version: 9.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Ursofalk
INN or Proposed INN: URSODEOXYCHOLIC ACID
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
183Phase 3Hungary;Finland;United Kingdom;Germany;Netherlands;Denmark;France;Spain;Italy;Austria;Lithuania;Sweden
13EUCTR2007-004040-70-NL
(EUCTR)
11/08/200823/06/2008Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosisDouble-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflammatory activity in the histological assessment of the liver
MedDRA version: 18.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Ursofalk
INN or Proposed INN: URSODEOXYCHOLIC ACID
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
144Phase 3Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Netherlands;Germany;Sweden
14EUCTR2007-004040-70-DE
(EUCTR)
15/05/200814/03/2008Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosisDouble-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflammatory activity in the histological assessment of the liver
MedDRA version: 18.0;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Ursofalk
INN or Proposed INN: URSODEOXYCHOLIC ACID
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
144Phase 3Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;Sweden
15NCT00587119
(ClinicalTrials.gov)
December 200721/12/2007Oral Budesonide in the Treatment of Patients With Primary Biliary Cirrhosis and Overlap Features of Autoimmune HepatitisOpen-Label Pilot Study Evaluating Oral Budesonide in the Treatment of Patients With Primary Biliary Cirrhosis and Overlap Features of Autoimmune Hepatitis.Primary Biliary Cirrhosis;Autoimmune HepatitisDrug: BudesonideMayo ClinicNULLWithdrawn21 Years75 YearsBoth0N/AUnited States

94. 原発性硬化性胆管炎 [臨床試験数:134,薬物数:105(DrugBank:37),標的遺伝子数:18,標的パスウェイ数:131
Searched query = "Primary sclerosing cholangitis", "PSC"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
1 / 134 trial found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00004842
(ClinicalTrials.gov)
May 199724/2/2000Pilot Study of Budesonide for Patients With Primary Sclerosing CholangitisPilot Study of Budesonide for Patients With Primary Sclerosing CholangitisCholangitis, Sclerosing;Liver Cirrhosis, BiliaryDrug: budesonideNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Mayo ClinicCompleted18 Years70 YearsAll22Phase 1United States

95. 自己免疫性肝炎 [臨床試験数:44,薬物数:57(DrugBank:26),標的遺伝子数:18,標的パスウェイ数:108
Searched query = "Autoimmune hepatitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
2 / 44 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00587119
(ClinicalTrials.gov)
December 200721/12/2007Oral Budesonide in the Treatment of Patients With Primary Biliary Cirrhosis and Overlap Features of Autoimmune HepatitisOpen-Label Pilot Study Evaluating Oral Budesonide in the Treatment of Patients With Primary Biliary Cirrhosis and Overlap Features of Autoimmune Hepatitis.Primary Biliary Cirrhosis;Autoimmune HepatitisDrug: BudesonideMayo ClinicNULLWithdrawn21 Years75 YearsBoth0N/AUnited States
2NCT00838214
(ClinicalTrials.gov)
March 20015/2/2009Budesonide 3x3mg/d Versus Prednisone in Active Autoimmune HepatitisEfficacy and Safety of Budesonide Capsules (3x3mg/d)Versus Prednisone in Patients With a Diagnose of Active Autoimmune Hepatitis. A Double-blind, Randomized, Active-controlled, Multicentre StudyAutoimmune HepatitisDrug: budesonide;Drug: prednisoneDr. Falk Pharma GmbHNULLCompleted10 Years70 YearsAll208Phase 2/Phase 3Germany

96. クローン病 [臨床試験数:2,209,薬物数:1,276(DrugBank:240),標的遺伝子数:166,標的パスウェイ数:210
Searched query = "Crohn disease", "Terminal ileitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
27 / 2,209 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04233463
(ClinicalTrials.gov)
January 202015/1/2020The Effect of Oral Polymeric Diet Enriched With TGF-beta 2 (Modulen) on Clinical Response and Mucosal Healing in Adult Patients With Newly Diagnosed Crohn's DiseaseThe Effect of Oral Polymeric Diet Enriched With TGF-beta 2 (Modulen) on Clinical Response and Mucosal Healing in Adult Patients With Newly Diagnosed Crohn's Disease: a Prospective, Randomized StudyCrohn DiseaseDietary Supplement: Modulen;Drug: BudesonideHillel Yaffe Medical CenterNULLNot yet recruiting18 Years70 YearsAll50N/AIsrael
2JPRN-jRCT1051190043
20/12/201802/09/2019Safety and efficacy of Budesonide administration after endoscopic balloon dilation for Crohn's disease patients with intestinal stenosisSafety and efficacy of Budesonide administration after endoscopic balloon dilation for Crohn's disease patients with intestinal stenosis - OGF1707 Crohn's diseaseAt the time of resumption of food after endoscopic balloon dilation, patients receive 9mg/day budesonide orally for 3 weeks, followed by 6mg/day for 1 week.Takehara TetsuoIijima HidekiRecruiting20ageNot applicableBoth15Phase 2Japan
3JPRN-UMIN000031839
2018/04/0101/04/2018Safety and efficacy of Budesonide administration after endoscopic ballon dilation for Crohn disease patients with intestinal stenosisSafety and efficacy of Budesonide administration after endoscopic ballon dilation for Crohn disease patients with intestinal stenosis - Safety and efficacy of Budesonide administration after EBD for CD patients Crohn's diseaseAt the time of resumption of food, patients recerve 9mg/day budesonide orally for 3 weeks, followed by 6mg/day for 1 week.Osaka University Graduate School of MedicineDepartment of Gastroenterology and HepatologyJapan Community Health care Organizationi Osaka Hospital, Gastroenterology and HepatologyNational Hospital Organization Osaka National Hospital, Gastroenterology and HepatologyOsaka Rosai Hospital , Gastroenterology and HepatologyKansai Rosai Hospital, Gastroenterology and HepatologyItami City Hospital, Gastroenterology and HepatologyHyogo Prefectural Nishinomiya Hospital, Gastroenterology and HepatologyNishinomiya Municipal central hospital, Gastroenterology and HepatologyRecruiting20years-oldNot applicableMale and Female15Not selectedJapan
4JPRN-jRCTs021200013
28/02/201831/07/2020A comparison between combination therapy of Ustekinumab boosted by Budesonide and monotherapy of Ustekinumab for Crohn's disease.A comparison of remission rate at 8 weeks between combination therapy of Ustekinumab and Budesonide and monotherapy of Ustekinumab in moderate to severe Japanese Crohn's disease; A phase III, single-center, double blind, randomized control trial. - BUUST Crohn's disease
Crohn's disease;D003424
Ustekinumab monotherapy for 32 weeks.Moroi RintaoNULLRecruiting>= 18age old<= 75age oldBoth80Phase 3Japan
5JPRN-UMIN000030884
2018/02/2720/02/2018A comparison of remission rate at 8 weeks between combination therapy of Ustekinumab and Budesonide and monotherapy of Ustekinumab in moderate to severe Japanese Crohn's disease; A phase III, single-center, double blind, randomized control trial. Crohn's diseaseUstekinumab monotherapy for 32 weeks.
Combination of Budesonide and Ustekinumab for 32 weeks.
Tohoku University Hospital, Division of GastroenterologyNULLRecruiting18years-old75years-oldMale and Female80Phase 3Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6JPRN-JapicCTI-184152
01/9/201711/10/2018Investigation of the safety and efficacy of Budesonide ( Zentacort Capsules ) in patients with Crohn's diseaseInvestigation of the safety and efficacy of Budesonide ( Zentacort Capsules ) in patients with Crohn's disease Crohn's diseaseIntervention name : Budesonide ( Zentacort Capsules 3mg )
INN of the intervention : Budesonide
Dosage And administration of the intervention : Oral
ZERIA Pharmaceutical Co., Ltd.NULLrecruitingBOTH200NANULL
7NCT01783106
(ClinicalTrials.gov)
February 1, 201431/1/2013Antibiotics and Hydroxychloroquine in Crohn'sA Pilot Randomised Study to Compare Combination Antibiotic Therapy (Ciprofloxacin, Doxycycline and Hydroxychloroquine) With Standard Therapy (Budesonide) in the Treatment of Active Crohn's DiseaseCrohn's DiseaseDrug: Ciprofloxacin;Drug: Doxycycline;Drug: Hydroxychloroquine;Drug: BudesonideRoyal Liverpool University HospitalNational Association for Colitis and Crohn's Disease;National Institute for Health Research, United KingdomCompleted18 YearsN/AAll59Phase 2United Kingdom
8EUCTR2011-003743-22-IT
(EUCTR)
01/12/201108/03/2012A Multicenter, Open label, Non-Comparative Study to Evaluate the Safety of Entocort EC for the Treatment of Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, InclusiveA Multicenter, Open label, Non-Comparative Study to Evaluate the Safety of Entocort EC for the Treatment of Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive Crohn's Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Entocort
INN or Proposed INN: BUDESONIDE
ASTRAZENECANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
110United States;Canada;Germany;Italy
9EUCTR2008-006957-42-BG
(EUCTR)
17/11/200921/08/2009Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s diseaseDouble-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s disease Induction of remission in active Crohn´s disease
MedDRA version: 12.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode
MedDRA version: 12.0;Level: PT;Classification code 10011401;Term: Crohn's disease
Product Name: Budenofalk 9mg gastro-resistant granules
Product Code: Budenofalk 9mg gastro-resistant granules
INN or Proposed INN: BUDESONIDE
Trade Name: Budenofalk 3mg gastro-resistant capsules
Product Name: Budenofalk 3mg gastro-resistant capsules
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Hungary;Slovakia;Czech Republic;Germany;Bulgaria;Latvia;Lithuania
10NCT01086553
(ClinicalTrials.gov)
November 200912/3/20109 mg Budesonide Once Daily (OD) Versus 3 mg Budesonide Three Times Daily (TID) in Active Crohn's DiseaseDouble-blind, Double-dummy, Randomised, Comparative, Multi-centre Phase III Study on the Efficacy and Tolerability of an 8-week Oral Treatment With 9 mg Budesonide Once Daily vs. 3 mg Budesonide Three-times Daily in Patients With Active Crohn's DiseaseCrohn´s DiseaseDrug: budesonideDr. Falk Pharma GmbHNULLCompleted18 Years75 YearsBoth471Phase 3Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2008-006957-42-DE
(EUCTR)
30/10/200930/07/2009Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s diseaseDouble-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s disease Induction of remission in active Crohn´s disease
MedDRA version: 14.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
Product Name: Budenofalk 9mg gastro-resistant granules
Product Code: Budenofalk 9mg gastro-resistant granules
INN or Proposed INN: BUDESONIDE
Trade Name: Budenofalk 3mg gastro-resistant capsules
Product Name: Budenofalk 3mg gastro-resistant capsules
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
500Phase 3Hungary;Czech Republic;Slovakia;Ukraine;Romania;Lithuania;Russian Federation;Bulgaria;Latvia;Germany
12EUCTR2008-006957-42-LT
(EUCTR)
19/10/200912/08/2009Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s diseaseDouble-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s disease Induction of remission in active Crohn´s disease
MedDRA version: 14.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
Product Name: Budenofalk 9mg gastro-resistant granules
Product Code: Budenofalk 9mg gastro-resistant granules
INN or Proposed INN: BUDESONIDE
Trade Name: Budenofalk 3mg gastro-resistant capsules
Product Name: Budenofalk 3mg gastro-resistant capsules
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
500Phase 3Hungary;Germany;Czech Republic;Slovakia;Russian Federation;Ukraine;Bulgaria;Romania;Latvia;Lithuania
13EUCTR2008-006957-42-SK
(EUCTR)
14/10/200919/10/2009Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s diseaseDouble-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s disease Induction of remission in active Crohn´s disease
MedDRA version: 12.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode
MedDRA version: 12.0;Level: PT;Classification code 10011401;Term: Crohn's disease
Product Name: Budenofalk 9mg gastro-resistant granules
Product Code: Budenofalk 9mg gastro-resistant granules
INN or Proposed INN: BUDESONIDE
Trade Name: Budenofalk 3mg gastro-resistant capsules
Product Name: Budenofalk 3mg gastro-resistant capsules
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Czech Republic;Hungary;Slovakia;Lithuania;Bulgaria;Latvia;Germany
14EUCTR2008-006957-42-LV
(EUCTR)
25/09/200908/09/2009Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s diseaseDouble-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s disease Induction of remission in active Crohn´s disease
MedDRA version: 14.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
Product Name: Budenofalk 9mg gastro-resistant granules
Product Code: Budenofalk 9mg gastro-resistant granules
INN or Proposed INN: BUDESONIDE
Trade Name: Budenofalk 3mg gastro-resistant capsules
Product Name: Budenofalk 3mg gastro-resistant capsules
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Czech Republic;Hungary;Slovakia;Lithuania;Bulgaria;Germany;Latvia
15EUCTR2008-006957-42-CZ
(EUCTR)
24/09/200907/09/2009Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s diseaseDouble-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s disease Induction of remission in active Crohn´s disease
MedDRA version: 12.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode
MedDRA version: 12.0;Level: PT;Classification code 10011401;Term: Crohn's disease
Product Name: Budenofalk 9mg gastro-resistant granules
Product Code: Budenofalk 9mg gastro-resistant granules
INN or Proposed INN: BUDESONIDE
Trade Name: Budenofalk 3mg gastro-resistant capsules
Product Name: Budenofalk 3mg gastro-resistant capsules
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Hungary;Slovakia;Germany;Czech Republic;Bulgaria;Latvia;Lithuania
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2008-006957-42-HU
(EUCTR)
16/09/200904/08/2009Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s diseaseDouble-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s disease Induction of remission in active Crohn´s disease
MedDRA version: 12.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode
MedDRA version: 12.0;Level: PT;Classification code 10011401;Term: Crohn's disease
Product Name: Budenofalk 9mg gastro-resistant granules
Product Code: Budenofalk 9mg gastro-resistant granules
INN or Proposed INN: BUDESONIDE
Trade Name: Budenofalk 3mg gastro-resistant capsules
Product Name: Budenofalk 3mg gastro-resistant capsules
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Hungary;Slovakia;Czech Republic;Germany;Bulgaria;Latvia;Lithuania
17EUCTR2008-001137-99-GB
(EUCTR)
28/04/200927/11/2008 CHANGE TO: A PILOT RANDOMISED STUDY TO COMPARE COMBINATION ANTIBIOTIC THERAPY (CIPROFLOXACIN AND DOXYCYCLINE) WITH STANDARD THERAPY (BUDESONIDE) IN THE TREATMENT OF ACTIVE CROHN'S DISEASE - Combination antibiotic therapy in treatment of active Crohn's disease CHANGE TO: A PILOT RANDOMISED STUDY TO COMPARE COMBINATION ANTIBIOTIC THERAPY (CIPROFLOXACIN AND DOXYCYCLINE) WITH STANDARD THERAPY (BUDESONIDE) IN THE TREATMENT OF ACTIVE CROHN'S DISEASE - Combination antibiotic therapy in treatment of active Crohn's disease Crohn's Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
Royal Liverpool & Broadgreen University Hospitals TrustUniversity of LiverpoolNot Recruiting Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom
18EUCTR2007-005455-42-NL
(EUCTR)
26/02/200918/09/2008ENDO ACE TRIALEndoscopic Balloon Dilatation of stenotic ileocecal anastomosis in Crohn´s disease with or without additive local steroid injection and oral Budenofalk;a randomized controlled trial - ENDO ACE TRIALENDO ACE TRIALEndoscopic Balloon Dilatation of stenotic ileocecal anastomosis in Crohn´s disease with or without additive local steroid injection and oral Budenofalk;a randomized controlled trial - ENDO ACE TRIAL Crohn's disease.Patients with Crohn's disease with status after ileocecal resection. Stenotic ileocecal anastomosis with symptoms of obstruction.
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders
Trade Name: Budenofalk
Product Name: Budenofalk
INN or Proposed INN: BUDESONIDE
Trade Name: Kenacort
Product Name: Kenacort
INN or Proposed INN: TRIAMCINOLONE
University Medical Center UtrechtNULLNot RecruitingFemale: yes
Male: yes
42Netherlands
19EUCTR2004-001213-34-GB
(EUCTR)
30/01/200719/08/2008Double-blind, double-dummy, randomized, multicentre study to compare the efficacy and safety of oral budesonide (9 mg) and oral mesalazine (4.5 g) in moderately active Crohn’s disease patients - Oral budesonide vs. oral mesalazine in active CDDouble-blind, double-dummy, randomized, multicentre study to compare the efficacy and safety of oral budesonide (9 mg) and oral mesalazine (4.5 g) in moderately active Crohn’s disease patients - Oral budesonide vs. oral mesalazine in active CD moderately active Crohn’s disease (200 < CDAI < 400)
MedDRA version: 7.0;Level: PT;Classification code 10011401
Trade Name: Salofalk
INN or Proposed INN: mesalazine
Other descriptive name: 5-Aminosalicyl acid
Trade Name: Budenofalk
INN or Proposed INN: budesonide
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
370Czech Republic;United Kingdom
20EUCTR2004-001213-34-SK
(EUCTR)
16/12/200416/08/2005Double-blind, double-dummy, randomized, multicentre study to compare the efficacy and safety of oral budesonide (9 mg) and oral mesalazine (4.5 g) in moderately active Crohn’s disease patients - Oral budesonide vs. oral mesalazine in active CDDouble-blind, double-dummy, randomized, multicentre study to compare the efficacy and safety of oral budesonide (9 mg) and oral mesalazine (4.5 g) in moderately active Crohn’s disease patients - Oral budesonide vs. oral mesalazine in active CD moderately active Crohn’s disease (200 < CDAI < 400)
MedDRA version: 7.0;Level: PT;Classification code 10011401
INN or Proposed INN: mesalazine
INN or Proposed INN: budesonide
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
370Phase 3Czech Republic;Slovakia;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2004-001213-34-CZ
(EUCTR)
02/11/200402/11/2004Double-blind, double-dummy, randomized, multicentre study to compare the efficacy and safety of oral budesonide (9 mg) and oral mesalazine (4.5 g) in moderately active Crohn’s disease patients - Oral budesonide vs. oral mesalazine in active CDDouble-blind, double-dummy, randomized, multicentre study to compare the efficacy and safety of oral budesonide (9 mg) and oral mesalazine (4.5 g) in moderately active Crohn’s disease patients - Oral budesonide vs. oral mesalazine in active CD moderately active Crohn’s disease (200 < CDAI < 400)
MedDRA version: 7.0;Level: PT;Classification code 10011401
INN or Proposed INN: mesalazine
INN or Proposed INN: budesonide
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
370United Kingdom;Czech Republic
22NCT00300118
(ClinicalTrials.gov)
September 20047/3/2006Oral Budesonide vs. Oral Mesalazine in Active Crohn's Disease (CD)Double-blind, Double-dummy, Randomized, Multicentre Study to Compare the Efficacy and Safety of Oral Budesonide (9 mg) and Oral Mesalazine (4.5 g) in Moderately Active Crohn's Disease PatientsCrohn's DiseaseDrug: budesonide;Drug: mesalazineDr. Falk Pharma GmbHNULLCompleted18 Years70 YearsBoth311Phase 3Germany
23NCT00554710
(ClinicalTrials.gov)
May 20016/11/2007Top Down Versus Step Up Strategies in Crohn's DiseaseThe Ideal Management of Crohn's Disease: Top Down Versus Step Up Strategies. A Prospective Controlled Trial in the BeneluxCrohn's DiseaseDrug: infliximab+azathioprine;Drug: methylprednisolone or budesonideBelgian IBD Research GroupCentocor BV;Schering-PloughCompleted16 Years75 YearsBoth129Phase 4Belgium
24JPRN-JapicCTI-080566
09/04/2008A Multicentre, Double-Blind, Randomised, Parallel-Group, Phase II Study to Assess Efficacy and Safety of D9421-C 9 mg and 15 mg Versus Placebo in Japanese Patients With Active Crohn's DiseaseA Multicentre, Double-Blind, Randomised, Parallel-Group, Phase II Study to Assess Efficacy and Safety of D9421-C 9 mg and 15 mg Versus Placebo in Japanese Patients With Active Crohn's Disease Crohn's DiseaseIntervention name : Budesonide
Dosage And administration of the intervention : Oral
AstraZenecaNULL1865BOTHPhase 2NULL
25EUCTR2014-004132-20-Outside-EU/EEA
(EUCTR)
28/07/2016Phase III study to assess efficacy and safety of D9421-C 9 mg with active Crohn’s Disease in JapanA multicentre, double-blind, randomised, parallel-group, Phase III study to assess efficacy and safety of D9421-C 9 mg versus Mesalazine 3 g in patients with active Crohn’s Disease in Japan Active Crohn’s Disease
MedDRA version: 19.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Entocort
Product Code: D9421-C
INN or Proposed INN: budesonide
Trade Name: Pentasa
INN or Proposed INN: mesalazine
AstraZeneca K.K.NULLNAFemale: yes
Male: yes
112Phase 3Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2011-003743-22-DE
(EUCTR)
20/10/2011A Multicenter, Open label, Non-Comparative Study to Evaluate the Safety of Entocort EC for the Treatment of Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, InclusiveA Multicenter, Open label, Non-Comparative Study to Evaluate the Safety of Entocort EC for the Treatment of Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive Crohn's Disease;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]Trade Name: Entocort® Kapseln
Product Name: budesonide
INN or Proposed INN: budesonide
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
110United States;Canada;Poland;Germany;Italy
27EUCTR2011-003742-40-DE
(EUCTR)
20/10/2011A Multicenter, Open label, Non-Comparative Study to Evaluate the Safety of Entocort™ EC as a Maintenance Treatment for Crohn’s Disease in Paediatric Subjects Aged 5 to 17 Years, InclusiveA Multicenter, Open label, Non-Comparative Study to Evaluate the Safety of Entocort™ EC as a Maintenance Treatment for Crohn’s Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive Crohn's Disease
MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Trade Name: Entocort® Kapseln
Product Name: budesonide
INN or Proposed INN: BUDESONIDE
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
50United States;Canada;Poland;Germany;Italy

97. 潰瘍性大腸炎 [臨床試験数:2,269,薬物数:1,331(DrugBank:241),標的遺伝子数:114,標的パスウェイ数:181
Searched query = "Ulcerative colitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
50 / 2,269 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04314375
(ClinicalTrials.gov)
April 202117/3/2020Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative ColitisA Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets n Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative ColitisUlcerative ColitisDrug: Low Dose Budesonide;Drug: High Dose Budesonide;Drug: PlaceboBausch Health Americas, Inc.NULLNot yet recruiting5 Years17 YearsAll70Phase 4NULL
2EUCTR2019-003334-16-DE
(EUCTR)
26/06/202005/05/2020Novel budenosid suppository in addition to basic therapy with oral mesalazine compared to basic therapy alone for treatment of ulcerative colitisRandomised, double-blind, placebo-controlled, multicentre study to compare the efficacy and safety of novel 4 mg budesonide suppository in combination with oral mesalazine versus oral mesalazine monotherapy in patients with acute ulcerative colitis acute ulcerative colitis
MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budenofalk® suppositories
INN or Proposed INN: BUDESONIDE
Other descriptive name: Budenofalk® suppositories (BUS)
Trade Name: Salofalk 3g gastro-resistant prolonged-release granules
Product Name: Salofalk 3g gastro-resistant prolonged-release granules
INN or Proposed INN: MESALAZINE
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 3Belarus;Poland;Ukraine;Russian Federation;Bulgaria;Latvia;Germany
3EUCTR2017-004576-57-PL
(EUCTR)
18/05/201901/08/2019Novel budesonide capsules vs. budesonide tabltes in patients with ulcerative colitis refractory to standard treatment with mesalazineRandomised, double-blind, double-dummy, active-controlled, phase III clinical trial on the efficacy and safety of an 8-week add-on treatment with budesonide 9 mg capsules vs. budesonide 6 mg capsules vs. budesonide-MMX® 9 mg tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine - TOPICAL-2 Patients with active ulcerative colitis refractory to standard treatment with mesalazine
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide 9 mg prolonged-release capsules, hard (BUX-PVII prototype)
INN or Proposed INN: BUDESONIDE
Product Name: Budesonide 6 mg prolonged-release capsules, hard (BUX-PVII prototype)
INN or Proposed INN: BUDESONIDE
Trade Name: CortimentMMX 9 mg
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
777Phase 3Hungary;Czech Republic;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany
4EUCTR2017-004576-57-DE
(EUCTR)
26/04/201908/01/2019Novel budesonide capsules vs. budesonide tablets in patients with ulcerative colitis refractory to standard treatment with mesalazineRandomised, double-blind, double-dummy, active-controlled, phase III clinical trial on the efficacy and safety of an 8-week add-on treatment with budesonide 9 mg capsules vs. budesonide 6 mg capsules vs. budesonide-MMX® 9 mg tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine - TOPICAL-2 Patients with active ulcerative colitis refractory to standard treatment with mesalazine
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide 9 mg prolonged-release capsule, hard (BUX-PVII prototype)
INN or Proposed INN: BUDESONIDE
Product Name: Budesonide 6 mg prolonged-release capsule, hard (BUX-PVII prototype)
INN or Proposed INN: BUDESONIDE
Trade Name: CortimentMMX 9 mg
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
777Phase 3Serbia;Czechia;Czech Republic;Hungary;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany
5EUCTR2017-004576-57-LV
(EUCTR)
15/04/201914/01/2019Novel budesonide capsules vs. budesonide tables in patients with ulcerative colitis refractory to standard treatment with mesalazineRandomised, double-blind, double-dummy, active-controlled, phase III clinical trial on the efficacy and safety of an 8-week add-on treatment with budesonide 9 mg capsules vs. budesonide 6 mg capsules vs. budesonide-MMX® 9 mg tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine - TOPICAL-2 Patients with active ulcerative colitis refractory to standard treatment with mesalazine
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
777 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noHungary;Czech Republic;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Germany;Latvia
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2017-004576-57-CZ
(EUCTR)
27/03/201915/03/2019Novel budesonide capsules vs. budesonide tablets in patients with ulcerative colitis refractory to standard treatment with mesalazineRandomised, double-blind, double-dummy, active-controlled, phase III clinical trial on the efficacy and safety of an 8-week add-on treatment with budesonide 9 mg capsules vs. budesonide 6 mg capsules vs. budesonide-MMX® 9 mg tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine - TOPICAL-2 Patients with active ulcerative colitis refractory to standard treatment with mesalazine
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide 9 mg prolonged-release capsules, hard (BUX-PVII prototype)
INN or Proposed INN: BUDESONIDE
Product Name: Budesonide 6 mg prolonged-release capsules, hard (BUX-PVII prototype)
INN or Proposed INN: BUDESONIDE
Trade Name: CortimentMMX 9 mg
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
777Phase 3Hungary;Czech Republic;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany
7EUCTR2017-004576-57-LT
(EUCTR)
15/03/201929/01/2019Novel budesonide capsules vs. budesonide tablets in patients with ulcerative colitis refractory to standard treatment with mesalazineRandomised, double-blind, double-dummy, active-controlled, phase III clinical trial on the efficacy and safety of an 8-week add-on treatment with budesonide 9 mg capsules vs. budesonide 6 mg capsules vs. budesonide-MMX® 9 mg tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine - TOPICAL-2 Patients with active ulcerative colitis refractory to standard treatment with mesalazine
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide 9 mg prolonged-release capsule, hard (BUX-PVII prototype)
INN or Proposed INN: BUDESONIDE
Product Name: Budesonide 6 mg prolonged-release capsule, hard (BUX-PVII prototype)
INN or Proposed INN: BUDESONIDE
Trade Name: CortimentMMX 9 mg
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
777Phase 3Hungary;Czech Republic;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany
8EUCTR2017-004576-57-SK
(EUCTR)
12/03/201918/01/2019Novel budesonide capsules vs. budesonide tablets in patients with ulcerative colitis refractory to standard treatment with mesalazineRandomised, double-blind, double-dummy, active-controlled, phase III clinical trial on the efficacy and safety of an 8-week add-on treatment with budesonide 9 mg capsules vs. budesonide 6 mg capsules vs. budesonide-MMX® 9 mg tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine - TOPICAL-2 Patients with active ulcerative colitis refractory to standard treatment with mesalazine
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide 9 mg prolonged-release capsules, hard (BUX-PVII prototype)
INN or Proposed INN: BUDESONIDE
Product Name: Budesonide 6 mg prolonged-release capsules, hard (BUX-PVII prototype)
INN or Proposed INN: BUDESONIDE
Trade Name: CortimentMMX 9 mg
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
777Phase 3Hungary;Czech Republic;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany
9EUCTR2017-004576-57-HU
(EUCTR)
11/03/201916/01/2019Novel budesonide capsules vs. budesonide tablets in patients with ulcerative colitis refractory to standard treatment with mesalazineRandomised, double-blind, double-dummy, active-controlled, phase III clinical trial on the efficacy and safety of an 8-week add-on treatment with budesonide 9 mg capsules vs. budesonide 6 mg capsules vs. budesonide-MMX® 9 mg tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine - TOPICAL-2 Patients with active ulcerative colitis refractory to standard treatment with mesalazine
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide 9 mg prolonged-release capsules, hard (BUX-PVII prototype)
INN or Proposed INN: BUDESONIDE
Product Name: Budesonide 6 mg prolonged-release capsules, hard (BUX-PVII prototype)
INN or Proposed INN: BUDESONIDE
Trade Name: CortimentMMX 9 mg
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
777Phase 3Czech Republic;Hungary;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany
10JPRN-UMIN000034016
2018/12/0103/09/2018The investigation for maintenance therapy by mesalazine enema after remission induction by budesonide form enema in patients with ulcerative colitis: Multicenter randomized controlled studyThe investigation for maintenance therapy by mesalazine enema after remission induction by budesonide form enema in patients with ulcerative colitis: Multicenter randomized controlled study - STABILITY study ulcerative colitisAdditional remission maintenance therapy by mesalazine enema with continuation of concomitant treatment at the remission induction by budesonide form enema
The continuation of concomitant treatment at the remission induction by budesonide form enema (control group)
Hyogo College of MedicineNULLComplete: follow-up complete16years-oldNot applicableMale and Female84Not selectedJapan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT03412682
(ClinicalTrials.gov)
March 2, 201822/1/2018To Evaluate the Efficacy and Safety of FE 999315 in Japanese Subjects With Mild to Moderate Active Ulcerative ColitisA Phase 3, Multi-centre, Randomised, Double-blind, Active-controlled, Parallel-group Trial Investigating the Efficacy and Safety of FE 999315 Following 8 Weeks of Treatment for Mild to Moderate Active Ulcerative Colitis in Japanese SubjectsColitis, UlcerativeDrug: Budesonide (6 mg);Drug: Budesonide (9 mg);Drug: Mesalazine (3,600 mg)Ferring PharmaceuticalsNULLCompleted16 Years75 YearsAll274Phase 3Japan
12JPRN-JapicCTI-183858
01/2/201808/02/2018Prospective, Post Marketing Surveillance of RECTABUL2mg rectal formProspective, Post Marketing Surveillance of RECTABUL2mg rectal form Ulcerative colitis (except for severe disease)Intervention name : RECTABUL2mg rectal form
INN of the intervention : Budesonide
Dosage And administration of the intervention : Usually, this drug is administered 2 times (1time 2mg) daily through rectal.
EA Pharma Co.,Ltd.KISSEI Pharmaceutical Co., Ltd.recruitingBOTH600NANULL
13NCT02586259
(ClinicalTrials.gov)
December 201523/10/2015Effectiveness of Cortiment® in Patients With Ulcerative ColitisA Prospective Multi-centre Observational Cohort Study Assessing the Effectiveness of Cortiment® for the Treatment of Mild-to-moderate Active Ulcerative Colitis in Routine Clinical PracticeUlcerative ColitisDrug: budesonide MMX®Ferring PharmaceuticalsNULLCompleted18 YearsN/AAll378Canada;Germany;Ireland;Italy;Netherlands;Poland;Sweden;United Kingdom;Israel;Switzerland
14EUCTR2014-005635-14-LT
(EUCTR)
21/10/201503/07/2015Open-label, multi-centre, proof of concept phase IIa clinical trial on the efficacy and tolerability of an 8 week oral treatment with once daily 9 mg budesonide in patients with active ulcerative colitisOpen-label, multi-centre, proof of concept phase IIa clinical trial on the efficacy and tolerability of an 8 week oral treatment with once daily 9 mg budesonide in patients with active ulcerative colitis - Budesonide 9 mg capsules in active UC Patients with active ulcerative colitis
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide 9 mg capsules, hard (BUX-PV)
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
60Phase 2Hungary;Lithuania;Latvia
15NCT02550418
(ClinicalTrials.gov)
October 201514/9/2015Budesonide 9 mg Capsules in Active UCOpen-label, Multi-centre, Proof of Concept Phase IIa Clinical Trial on the Efficacy and Tolerability of an 8 Week Oral Treatment With Once Daily 9 mg Budesonide in Patients With Active Ulcerative ColitisColitis, UlcerativeDrug: BudesonideDr. Falk Pharma GmbHNULLCompleted18 Years75 YearsAll60Phase 2Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2014-005635-14-HU
(EUCTR)
29/07/201503/06/2015Open-label, multi-centre, proof of concept phase IIa clinical trial on the efficacy and tolerability of an 8 week oral treatment with once daily 9 mg budesonide in patients with active ulcerative colitisOpen-label, multi-centre, proof of concept phase IIa clinical trial on the efficacy and tolerability of an 8 week oral treatment with once daily 9 mg budesonide in patients with active ulcerative colitis - Budesonide 9 mg capsules in active UC Patients with active ulcerative colitis
MedDRA version: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide 9 mg capsules, hard (BUX-PV)
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
60Phase 2Hungary;Lithuania;Latvia
17EUCTR2014-005635-14-LV
(EUCTR)
10/07/201523/02/2015Open-label, multi-centre, proof of concept phase IIa clinical trial on the efficacy and tolerability of an 8 week oral treatment with once daily 9 mg budesonide in patients with active ulcerative colitisOpen-label, multi-centre, proof of concept phase IIa clinical trial on the efficacy and tolerability of an 8 week oral treatment with once daily 9 mg budesonide in patients with active ulcerative colitis - Budesonide 9 mg capsules in active UC Patients with active ulcerative colitis
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide 9 mg capsules, hard (BUX-PV)
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
60Phase 2Hungary;Lithuania;Latvia
18EUCTR2014-005635-14-DE
(EUCTR)
08/06/201518/02/2015Open-label, multi-centre, proof of concept phase IIa clinical trial on the efficacy and tolerability of an 8 week oral treatment with once daily 9 mg budesonide in patients with active ulcerative colitisOpen-label, multi-centre, proof of concept phase IIa clinical trial on the efficacy and tolerability of an 8 week oral treatment with once daily 9 mg budesonide in patients with active ulcerative colitis - Budesonide 9 mg capsules in active UC Patients with active ulcerative colitis
MedDRA version: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide 9 mg capsules, hard (BUX-PV)
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
60Phase 2Hungary;Lithuania;Latvia;Germany
19JPRN-JapicCTI-142704
01/11/201414/11/2014Phase III study of AJG511 in patients with active ulcerative colitisPhase III study of AJG511 in patients with active ulcerative colitis ulcerative colitisIntervention name : AJG511
INN of the intervention : budesonide
Dosage And administration of the intervention : intrarectal
Control intervention name : Placebo
Dosage And administration of the control intervention : intrarectal
EA Pharma Co.,Ltd.NULL16BOTH120Phase 3NULL
20EUCTR2011-005115-82-LT
(EUCTR)
12/09/201224/05/2012An 8 week study to compare budesonide MMX 9 mg versus placebo in patients with mild to moderate ulcerative colitis who experience a flare of their disease while taking an existing 5 aminosalicylic acid.A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen Ulcerative Colitis
MedDRA version: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide-MMX®
INN or Proposed INN: BUDESONIDE
Santarus, Inc.NULLNot RecruitingFemale: yes
Male: yes
500United States;Hungary;Estonia;Czech Republic;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2011-005115-82-LV
(EUCTR)
15/06/201221/05/2012An 8 week study to compare budesonide MMX 9 mg versus placebo in patients with mild to moderate ulcerative colitis who experience a flare of their disease while taking an existing 5 aminosalicylic acid.A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide-MMX®
INN or Proposed INN: BUDESONIDE
Santarus, Inc.NULLNot RecruitingFemale: yes
Male: yes
500United States;Hungary;Estonia;Czech Republic;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia
22EUCTR2011-005115-82-EE
(EUCTR)
05/06/201209/05/2012An 8 week study to compare budesonide MMX 9 mg versus placebo in patients with mild to moderate ulcerative colitis who experience a flare of their disease while taking an existing 5 aminosalicylic acid.A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide-MMX®
INN or Proposed INN: BUDESONIDE
Santarus, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
500United States;Hungary;Czech Republic;Estonia;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia
23EUCTR2011-005115-82-BG
(EUCTR)
11/05/201211/04/2012An 8 week study to compare budesonide MMX 9 mg versus placebo in patients with mild to moderate ulcerative colitis who experience a flare of their disease while taking an existing 5 aminosalicylic acid.A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide-MMX®
INN or Proposed INN: BUDESONIDE
Santarus, Inc.NULLNot RecruitingFemale: yes
Male: yes
500United States;Estonia;Hungary;Czech Republic;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia
24EUCTR2011-005115-82-CZ
(EUCTR)
18/04/201208/02/2012An 8 week study to compare budesonide MMX 9 mg versus placebo in patients with mild to moderate ulcerative colitis who experience a flare of their disease while taking an existing 5 aminosalicylic acid.A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen Ulcerative Colitis
MedDRA version: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide-MMX®
INN or Proposed INN: BUDESONIDE
Santarus, Inc.NULLNot RecruitingFemale: yes
Male: yes
500United States;Estonia;Hungary;Czech Republic;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia
25EUCTR2011-005115-82-PL
(EUCTR)
10/04/201216/03/2012An 8 week study to compare budesonide MMX 9 mg versus placebo in patients with mild to moderate ulcerative colitis who experience a flare of their disease while taking an existing 5 aminosalicylic acid.A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen Ulcerative Colitis
MedDRA version: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide-MMX®
INN or Proposed INN: BUDESONIDE
Santarus, Inc.NULLNot RecruitingFemale: yes
Male: yes
500United States;Estonia;Hungary;Czech Republic;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2011-005115-82-HU
(EUCTR)
26/03/201207/02/2012An 8 week study to compare budesonide MMX 9 mg versus placebo in patients with mild to moderate ulcerative colitis who experience a flare of their disease while taking an existing 5 aminosalicylic acid.A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide-MMX®
INN or Proposed INN: BUDESONIDE
Santarus, Inc.NULLNot RecruitingFemale: yes
Male: yes
500United States;Estonia;Czech Republic;Hungary;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia
27NCT01532648
(ClinicalTrials.gov)
January 27, 201213/12/2011Randomized Placebo-Controlled Trial of Budesonide Multi-Matrix System (MMX®) 9 Milligrams (mg) in Participants With Ulcerative Colitis Currently on a 5-Aminosalicylic Acid (5-ASA)A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients With Active, Mild or Moderate Ulcerative Colitis Not Adequately Controlled on a Background Oral 5-ASA RegimenUlcerative ColitisDrug: Budesonide MMX®;Drug: Placebo;Drug: 5-ASABausch Health Americas, Inc.NULLCompleted18 Years75 YearsAll510Phase 3United States;Bulgaria;Canada;Czechia;Estonia;Hungary;Latvia;Lithuania;Poland;Russian Federation;Ukraine;Czech Republic
28NCT01100112
(ClinicalTrials.gov)
February 20106/4/2010(CB-01-02/06) Oral Budesonide-Multi-Matrix System (MMX) 9mg Extended Release TabletsMulticenter, Open-Label Efficacy and Safety Study of Oral Budesonide-MMX 9mg Extended Release Tablets in Patients With Mild to Moderate, Active Ulcerative ColitisColitis, UlcerativeDrug: BudesonideBausch Health Americas, Inc.Cosmo Technologies LtdCompleted18 Years75 YearsAll61Phase 3India
29EUCTR2008-003913-28-IT
(EUCTR)
25/05/200916/04/2009Randomised, double-blind,multicentre,12 months extension study to evaluate the safety and the efficacy of daily Budesonide MMX 6mg vs placebo in the maintenance of remission in subjects with ulcerative colitis. - NDRandomised, double-blind,multicentre,12 months extension study to evaluate the safety and the efficacy of daily Budesonide MMX 6mg vs placebo in the maintenance of remission in subjects with ulcerative colitis. - ND Mild to moderate ulcerative colitis.
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Product Name: Budesonide-MMX
Product Code: CB-01-02
INN or Proposed INN: Budesonide
COSMO TECHNOLOGIES LTDNULLNot RecruitingFemale: yes
Male: yes
150Italy
30NCT00801723
(ClinicalTrials.gov)
December 20082/12/2008(CB-01-02/04) Extension Study of Budesonide Multi-Matrix System (MMX) 6 mg in Maintenance Of Remission In Patients With Ulcerative Colitis.Randomised, Double-Blind, Multi-Centre, 12 Month Extension Study to Evaluate the Safety And Efficacy of Daily Budesonide MMX 6 mg Versus Placebo in the Maintenance of Remission in Subjects With Ulcerative Colitis.Ulcerative ColitisDrug: Budesonide MMX 6 mg Tablet;Drug: Placebo TabletBausch Health Americas, Inc.NULLCompleted18 Years75 YearsAll123Phase 3United States;Canada
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2006-004776-12-IT
(EUCTR)
15/10/200820/03/2009Efficacy and Safety of Oral Budesonide-MMX? (CB 01 02) 6 mg and 9 mg Extended Release Tablets in Patients with Mild or Moderate Active Ulcerative Colitis. A Multicentre, Randomised, Double-Blind, Double-Dummy, Comparative Study Versus Placebo with an Additional Reference Arm Evaluating EntocortEC. - CB-01-02/02Efficacy and Safety of Oral Budesonide-MMX? (CB 01 02) 6 mg and 9 mg Extended Release Tablets in Patients with Mild or Moderate Active Ulcerative Colitis. A Multicentre, Randomised, Double-Blind, Double-Dummy, Comparative Study Versus Placebo with an Additional Reference Arm Evaluating EntocortEC. - CB-01-02/02 Patients with mild or moderate active ulcerative colitis.
MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative
Product Name: Budesonide-MMX
Product Code: CB-01-02
INN or Proposed INN: Budesonide
Trade Name: ENTOCORT CR
INN or Proposed INN: Budesonide
Product Name: Budesonide MMX
Product Code: CB-01-02
INN or Proposed INN: Budesonide
COSMO TECHNOLOGIES LTDNULLNot RecruitingFemale: yes
Male: yes
492United Kingdom;Belgium;Estonia;France;Italy;Latvia;Lithuania;Sweden
32NCT00805285
(ClinicalTrials.gov)
October 20088/12/2008The Use of Oral Budesonide and Rectal Hydrocortisone for the Treatment of Active Ulcerative ColitisOral Budesonide and Rectal Hydrocortisone for the Treatment of Extensive Ulcerative Colitis: A Pilot StudyInflammatory Bowel Disease;Ulcerative ColitisDrug: Combination Oral Budesonide and Rectal HydrocortisoneUniversity of Maryland, BaltimoreNULLTerminated18 YearsN/AAll1Phase 2United States
33EUCTR2006-004776-12-SK
(EUCTR)
18/09/200816/07/2008Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®ECEfficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC Mild or moderate active ulcerative colitis.
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Product Name: Budesonide-MMX™
Product Code: CB-01-02
INN or Proposed INN: budesonide
Other descriptive name: CB-01-02
Trade Name: Entocort® CR
INN or Proposed INN: budesonide
Product Name: Budesonide-MMX
Product Code: CB-01-02
INN or Proposed INN: budesonide
Other descriptive name: CB-01-02
COSMO Technologies LtdNULLNot RecruitingFemale: yes
Male: yes
492Phase 3France;Estonia;Slovakia;Belgium;Lithuania;Latvia;Italy;United Kingdom;Sweden
34EUCTR2006-004776-12-EE
(EUCTR)
04/08/200811/06/2008Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®ECEfficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC Mild or moderate active ulcerative colitis.
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Product Name: Budesonide-MMX™
Product Code: CB-01-02
INN or Proposed INN: budesonide
Other descriptive name: CB-01-02
Trade Name: Entocort® CR
INN or Proposed INN: budesonide
Product Name: Budesonide-MMX
Product Code: CB-01-02
INN or Proposed INN: budesonide
Other descriptive name: CB-01-02
COSMO Technologies LtdNULLNot RecruitingFemale: yes
Male: yes
492United Kingdom;Belgium;France;Estonia;Italy;Latvia;Lithuania;Sweden
35EUCTR2006-004776-12-GB
(EUCTR)
23/07/200825/04/2008Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®ECEfficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC Mild or moderate active ulcerative colitis.
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Product Name: Budesonide-MMX™
Product Code: CB-01-02
INN or Proposed INN: budesonide
Other descriptive name: CB-01-02
Trade Name: Entocort® CR
INN or Proposed INN: budesonide
Product Name: Budesonide-MMX
Product Code: CB-01-02
INN or Proposed INN: budesonide
Other descriptive name: CB-01-02
COSMO Technologies LtdNULLNot RecruitingFemale: yes
Male: yes
492Phase 3France;Estonia;Slovakia;Belgium;Lithuania;Latvia;Italy;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2006-004776-12-FR
(EUCTR)
07/07/200809/05/2008Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®ECEfficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC Mild or moderate active ulcerative colitis.
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Product Name: Budesonide-MMX™
Product Code: CB-01-02
INN or Proposed INN: budesonide
Other descriptive name: CB-01-02
Trade Name: Entocort® CR
INN or Proposed INN: budesonide
Product Name: Budesonide-MMX
Product Code: CB-01-02
INN or Proposed INN: budesonide
Other descriptive name: CB-01-02
COSMO Technologies LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
492United Kingdom;Belgium;Estonia;France;Italy;Latvia;Lithuania;Sweden
37EUCTR2006-004776-12-BE
(EUCTR)
01/07/200818/06/2008Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®ECEfficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC Mild or moderate active ulcerative colitis.
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Product Name: Budesonide-MMX™
Product Code: CB-01-02
INN or Proposed INN: budesonide
Other descriptive name: CB-01-02
Trade Name: Entocort® CR
INN or Proposed INN: budesonide
Product Name: Budesonide-MMX
Product Code: CB-01-02
INN or Proposed INN: budesonide
Other descriptive name: CB-01-02
COSMO Technologies LtdNULLNot RecruitingFemale: yes
Male: yes
492United Kingdom;Belgium;Estonia;France;Italy;Latvia;Lithuania;Sweden
38EUCTR2006-004776-12-LT
(EUCTR)
17/06/200822/04/2008Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®ECEfficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC Mild or moderate active ulcerative colitis.
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Product Name: Budesonide-MMX™
Product Code: CB-01-02
INN or Proposed INN: budesonide
Other descriptive name: CB-01-02
Trade Name: Entocort® CR
INN or Proposed INN: budesonide
Product Name: Budesonide-MMX™
Product Code: CB-01-02
INN or Proposed INN: budesonide
Other descriptive name: CB-01-02
COSMO Technologies LtdNULLNot RecruitingFemale: yes
Male: yes
492United Kingdom;Belgium;Estonia;France;Italy;Latvia;Sweden;Lithuania
39EUCTR2006-004776-12-SE
(EUCTR)
02/06/200810/04/2008Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®ECEfficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC Mild or moderate active ulcerative colitis.
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Product Name: Budesonide-MMX™
Product Code: CB-01-02
INN or Proposed INN: budesonide
Other descriptive name: CB-01-02
Trade Name: Entocort® CR
INN or Proposed INN: budesonide
Product Name: Budesonide-MMX
Product Code: CB-01-02
INN or Proposed INN: budesonide
Other descriptive name: CB-01-02
COSMO Technologies LtdNULLNot RecruitingFemale: yes
Male: yes
492United Kingdom;Belgium;Estonia;France;Italy;Latvia;Lithuania;Sweden
40NCT00679380
(ClinicalTrials.gov)
June 200814/5/2008(CB-01-02/02) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative ColitisEfficacy and Safety of Oral Budesonide-MMX™ (CB-01-02) 6 mg and 9 mg Extended Release Tablets in Patients With Mild or Moderate Active Ulcerative Colitis. A Multicentre, Randomised, Double-Blind, Double-Dummy, Comparative Study Versus Placebo With an Additional Reference Arm Evaluating Entocort®ECUlcerative ColitisProcedure: Blood sampling, endoscopy;Drug: Budesonide MMX® 6 mg;Drug: Budesonide MMX® 9 mg;Drug: Entocort EC® 3 mg;Drug: PlaceboBausch Health Americas, Inc.Cosmo Technologies LtdCompleted18 Years75 YearsAll514Phase 3Australia;Belgium;Estonia;France;Israel;Italy;Latvia;Lithuania;Poland;Romania;Russian Federation;Slovakia;Sweden;Ukraine;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41NCT00679432
(ClinicalTrials.gov)
June 200814/5/2008(CB-01-02/01) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative ColitisEfficacy and Safety of New Oral Budesonide-MMX™ (CB-01-02) 6 mg and 9 mg Extended Release Tablet Formulations in Patients With Mild or Moderate, Active Ulcerative Colitis. A Multicenter, Randomized, Double-blind, Double Dummy Comparative Study Versus Placebo, With an Additional Reference Arm Evaluating Asacol® 2400 mg.Ulcerative ColitisProcedure: Blood sampling, endoscopy;Drug: budesonide-MMX® 6 mg;Drug: budesonide-MMX® 9 mg;Drug: Placebo;Drug: Asacol® 400 mgBausch Health Americas, Inc.NULLCompleted18 Years75 YearsAll510Phase 3United States;Canada;India;Mexico
42EUCTR2006-004776-12-LV
(EUCTR)
29/05/200829/04/2008Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®ECEfficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC Mild or moderate active ulcerative colitis.
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Product Name: Budesonide-MMX™
Product Code: CB-01-02
INN or Proposed INN: budesonide
Other descriptive name: CB-01-02
Trade Name: Entocort® CR
INN or Proposed INN: budesonide
Product Name: Budesonide-MMX
Product Code: CB-01-02
INN or Proposed INN: budesonide
Other descriptive name: CB-01-02
COSMO Technologies LtdNULLNot RecruitingFemale: yes
Male: yes
492United Kingdom;Belgium;Estonia;France;Italy;Latvia;Lithuania;Sweden
43EUCTR2006-005377-22-LT
(EUCTR)
13/11/200714/08/2007Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with 9 mg budesonide or 3 g mesalazine in patients with active ulcerative colitis - Budesonide capsules versus mesalazine granules in active UCDouble-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with 9 mg budesonide or 3 g mesalazine in patients with active ulcerative colitis - Budesonide capsules versus mesalazine granules in active UC Treatment of ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Salofalk 1000mg Granu-Stix
INN or Proposed INN: MESALAZINE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
360Phase 3Czech Republic;Germany;Spain;Latvia;Poland;Lithuania
44EUCTR2006-005377-22-DE
(EUCTR)
23/10/200716/07/2007Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with 9 mg budesonide or 3 g mesalazine in patients with active ulcerative colitis - Budesonide capsules versus mesalazine granules in active UCDouble-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with 9 mg budesonide or 3 g mesalazine in patients with active ulcerative colitis - Budesonide capsules versus mesalazine granules in active UC Treatment of ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Salofalk 1000mg Granu-Stix
INN or Proposed INN: MESALAZINE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
360Phase 3Czech Republic;Poland;Spain;Lithuania;Latvia;Germany
45NCT00747110
(ClinicalTrials.gov)
October 20073/9/2008Budesonide Capsules Versus Mesalazine Granules in Active Ulcerative Colitis (UC)Double-blind, Double-dummy, Randomised, Multi-centre, Comparative Phase III Clinical Study on the Efficacy and Tolerability of an 8 Week Oral Treatment With 9 mg Budesonide or 3 g Mesalazine in Patients With Active Ulcerative ColitisColitis, UlcerativeDrug: budesonide;Drug: mesalazineDr. Falk Pharma GmbHNULLCompleted18 Years75 YearsBoth343Phase 3Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46EUCTR2006-005377-22-LV
(EUCTR)
27/09/200712/09/2007Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with 9 mg budesonide or 3 g mesalazine in patients with active ulcerative colitis - Budesonide capsules versus mesalazine granules in active UCDouble-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with 9 mg budesonide or 3 g mesalazine in patients with active ulcerative colitis - Budesonide capsules versus mesalazine granules in active UC Treatment of ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Salofalk 1000mg Granu-Stix
INN or Proposed INN: MESALAZINE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
360Phase 3Czech Republic;Germany;Spain;Latvia;Poland;Lithuania
47EUCTR2006-005377-22-CZ
(EUCTR)
17/09/200714/09/2007Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with 9 mg budesonide or 3 g mesalazine in patients with active ulcerative colitis - Budesonide capsules versus mesalazine granules in active UCDouble-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with 9 mg budesonide or 3 g mesalazine in patients with active ulcerative colitis - Budesonide capsules versus mesalazine granules in active UC Treatment of ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Salofalk 1000mg Granu-stix®
INN or Proposed INN: MESALAZINE
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
360Phase 3Germany;Czech Republic;Spain;Latvia;Poland;Lithuania
48EUCTR2006-005377-22-SK
(EUCTR)
14/09/200716/04/2008Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with 9 mg budesonide or 3 g mesalazine in patients with active ulcerative colitis - Budesonide capsules versus mesalazine granules in active UCDouble-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with 9 mg budesonide or 3 g mesalazine in patients with active ulcerative colitis - Budesonide capsules versus mesalazine granules in active UC Treatment of ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Trade Name: Salofalk 1000mg Granu-Stix®
INN or Proposed INN: MESALAZINE
Trade Name: Budenofalk 3mg
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
360Phase 3Czech Republic;Slovakia;Poland;Spain;Lithuania;Latvia;Germany
49EUCTR2006-005377-22-PL
(EUCTR)
14/02/2008Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with 9 mg budesonide or 3 g mesalazine in patients with active ulcerative colitis - Budesonide capsules versus mesalazine granules in active UCDouble-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with 9 mg budesonide or 3 g mesalazine in patients with active ulcerative colitis - Budesonide capsules versus mesalazine granules in active UC Treatment of ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis
Dr. Falk Pharma GmbHNULLNot Recruiting Female: yes
Male: yes
360 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noCzech Republic;Slovakia;Spain;Poland;Lithuania;Latvia;Germany
50JPRN-JapicCTI-132294
03/10/2013Phase II study of AJG511 in patients with active ulcerative colitisPhase II study of AJG511 in patients with active ulcerative colitis Ulcerative colitisIntervention name : AJG511
INN of the intervention : budesonide
Dosage And administration of the intervention : intrarectal
Ajinomoto Pharmaceuticals Co., Ltd.NULL1669BOTHPhase 2NULL

98. 好酸球性消化管疾患 [臨床試験数:128,薬物数:147(DrugBank:40),標的遺伝子数:34,標的パスウェイ数:132
Searched query = "Eosinophilic gastrointestinal disease", "Eosinophilic gastroenteritis", "Eosinophilic esophagitis", "Eosinophilic colitis", "Eosinophilic gastro-intestinal disorder", "EGID", "Neonatal food-protein induced enterocolitis", "N-FPIES"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
34 / 128 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2017-003737-29-NL
(EUCTR)
01/04/202009/04/2019Double-blind (neither physician nor patient knows of the actual treatment which can be with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (one of the treatment groups receives medication without active substance), phase II/III study on the efficacy and tolerability of oral budesonide suspension in comparison with placebo in children and adolescents with eosinophilic esophagitisDouble-blind, randomized, placebo-controlled, Phase II/III trial on the efficacy and tolerability of treatment with budesonide oral suspension vs. placebo in children and adolescents with eosinophilic esophagitis - Budesonide oral suspension vs. placebo in pediatric eosinophilic esophagitis Active eosinophilic esophagitis and maintenance of remission in eosinophilic esophagitis
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide oral suspension [0.2 mg/ml]
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2;Phase 3Portugal;Greece;Spain;Israel;Germany;Netherlands;United Kingdom
2EUCTR2017-003737-29-GR
(EUCTR)
18/09/201903/09/2019Double-blind (neither physician nor patient knows of the actual treatment which can be with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (one of the treatment groups receives medication without active substance), phase II/III study on the efficacy and tolerability of oral budesonide suspension in comparison with placebo in children and adolescents with eosinophilic esophagitisDouble-blind, randomized, placebo-controlled, Phase II/III trial on the efficacy and tolerability of treatment with budesonide oral suspension vs. placebo in children and adolescents with eosinophilic esophagitis - Budesonide oral suspension vs. placebo in pediatric eosinophilic esophagitis Active eosinophilic esophagitis and maintenance of remission in eosinophilic esophagitis
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
75 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;Greece;Spain;Israel;Netherlands;Germany;United Kingdom
3EUCTR2017-003737-29-GB
(EUCTR)
01/08/201924/10/2019Double-blind (neither physician nor patient knows of the actual treatment which can be with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (one of the treatment groups receives medication without active substance), phase II/III study on the efficacy and tolerability of oral budesonide suspension in comparison with placebo in children and adolescents with eosinophilic esophagitisDouble-blind, randomized, placebo-controlled, Phase II/III trial on the efficacy and tolerability of treatment with budesonide oral suspension vs. placebo in children and adolescents with eosinophilic esophagitis - Budesonide oral suspension vs. placebo in pediatric eosinophilic esophagitis Active eosinophilic esophagitis and maintenance of remission in eosinophilic esophagitis
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
75 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;Greece;Spain;Israel;Netherlands;Germany;United Kingdom
4EUCTR2017-003737-29-PT
(EUCTR)
24/05/201929/01/2019Double-blind (neither physician nor patient knows of the actual treatment which can be with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (one of the treatment groups receives medication without active substance), phase II/III study on the efficacy and tolerability of oral budesonide suspension in comparison with placebo in children and adolescents with eosinophilic esophagitisDouble-blind, randomized, placebo-controlled, Phase II/III trial on the efficacy and tolerability of treatment with budesonide oral suspension vs. placebo in children and adolescents with eosinophilic esophagitis - Budesonide oral suspension vs. placebo in pediatric eosinophilic esophagitis Active eosinophilic esophagitis and maintenance of remission in eosinophilic esophagitis
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Budesonide oral suspension [0.2 mg/ml]
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 2;Phase 3Portugal;Greece;Spain;Israel;Netherlands;Germany;United Kingdom
5EUCTR2017-003737-29-ES
(EUCTR)
11/04/201918/01/2019Double-blind (neither physician nor patient knows of the actual treatment which can be with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (one of the treatment groups receives medication without active substance), phase II/III study on the efficacy and tolerability of oral budesonide suspension in comparison with placebo in children and adolescents with eosinophilic esophagitisDouble-blind, randomized, placebo-controlled, Phase II/III trial on the efficacy and tolerability of treatment with budesonide oral suspension vs. placebo in children and adolescents with eosinophilic esophagitis - Budesonide oral suspension vs. placebo in pediatric eosinophilic esophagitis Active eosinophilic esophagitis and maintenance of remission in eosinophilic esophagitis
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
75 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;Greece;Spain;Israel;Netherlands;Germany;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2014-001485-99-DK
(EUCTR)
27/10/201706/07/2017Double-blind (neither physician nor patient knows of the actual treatment which can with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets in comparison with placebo for maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitisDouble-blind, randomized, placebo-controlled, phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets vs. placebo for maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitis - Maintenance of remission with budesonide effervescent tabl. vs. placebo in eosinophilic esophagitis Maintenance of remission in eosinophilic esophagitis
MedDRA version: 20.0;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000013492;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: 1 mg budesonide effervescent tablet for orodispersible use
Product Code: BUET 1mg
INN or Proposed INN: BUDESONIDE
Product Name: 0.5 mg budesonide effervescent tablet for orodispersible use
Product Code: BUET 0.5 mg
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
204Phase 3Spain;Belgium;Denmark;Netherlands;United Kingdom;Switzerland
7NCT03245840
(ClinicalTrials.gov)
October 5, 20178/8/2017Continuation Study With Budesonide Oral Suspension (BOS) for Adolescent and Adult Participants With Eosinophilic Esophagitis (EoE)A Phase 3, Multicenter, Open-label Continuation Study With Budesonide Oral Suspension (BOS) for Adolescent and Adult Subjects With Eosinophilic Esophagitis (EoE)Eosinophilic Esophagitis (EoE)Drug: Budesonide oral suspensionShireNULLActive, not recruiting11 Years55 YearsAll133Phase 3United States
8EUCTR2014-001485-99-NL
(EUCTR)
24/08/201602/05/2016Double-blind (neither physician nor patient knows of the actual treatment which can with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets in comparison with placebo for maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitisDouble-blind, randomized, placebo-controlled, phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets vs. placebo for maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitis - Maintenance of remission with budesonide effervescent tabl. vs. placebo in eosinophilic esophagitis Maintenance of remission in eosinophilic esophagitis
MedDRA version: 19.0;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: 1 mg budesonide effervescent tablet for orodispersible use
Product Code: BUET 1mg
INN or Proposed INN: BUDESONIDE
Product Name: 0.5 mg budesonide effervescent tablet for orodispersible use
Product Code: BUET 0.5 mg
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
204Phase 3Spain;Belgium;Netherlands;United Kingdom;Switzerland
9NCT02736409
(ClinicalTrials.gov)
April 29, 201622/3/2016An Extension Study to Evaluate Maintenance of Efficacy and Long-term Treatment Effect of Oral Budesonide Suspension (OBS) in Adults and Adolescents With Eosinophilic Esophagitis (EoE)A Phase 3, Multicenter, Double-blind Extension Study to Evaluate Maintenance of Efficacy of Oral Budesonide Suspension (OBS) and Long-term Treatment Effect of OBS in Adolescent and Adult Subjects (11 to 55 Years of Age, Inclusive) With Eosinophilic Esophagitis (EoE)Eosinophilic Esophagitis (EoE)Drug: Oral Budesonide Suspension (OBS);Drug: PlaceboShireNULLCompleted11 Years55 YearsAll200Phase 3United States;United Kingdom
10EUCTR2014-001485-99-ES
(EUCTR)
22/01/201617/11/2015Double-blind (neither physician nor patient knows of the actual treatment which can with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets in comparison with placebo for maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitisDouble-blind, randomized, placebo-controlled, phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets vs. placebo for maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitis - Maintenance of remission with budesonide effervescent tabl. vs. placebo in eosinophilic esophagitis Maintenance of remission in eosinophilic esophagitis
MedDRA version: 18.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: 1 mg budesonide effervescent tablet for orodispersible use
Product Code: BUET 1mg
INN or Proposed INN: BUDESONIDE
Product Name: 0.5 mg budesonide effervescent tablet for orodispersible use
Product Code: BUET 0.5 mg
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
204Phase 3Spain;Switzerland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2014-001485-99-BE
(EUCTR)
22/01/201623/07/2015Double-blind (neither physician nor patient knows of the actual treatment which can with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets in comparison with placebo for maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitisDouble-blind, randomized, placebo-controlled, phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets vs. placebo for maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitis - Maintenance of remission with budesonide effervescent tabl. vs. placebo in eosinophilic esophagitis Maintenance of remission in eosinophilic esophagitis
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: 1 mg budesonide effervescent tablet for orodispersible use
Product Code: BUET 1mg
INN or Proposed INN: BUDESONIDE
Product Name: 0.5 mg budesonide effervescent tablet for orodispersible use
Product Code: BUET 0.5 mg
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
204Phase 3Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Switzerland
12NCT02493335
(ClinicalTrials.gov)
January 15, 20167/7/2015Maintenance of Remission With Budesonide Orodispersible Tablets vs. Placebo in Eosinophilic EsophagitisDouble-blind, Randomized, Placebo-controlled, Phase III Study on the Efficacy and Tolerability of a 48-week Treatment With Two Different Doses of Budesonide Effervescent Tablets vs. Placebo for Maintenance of Clinico-pathological Remission in Adult Patients With Eosinophilic EsophagitisEosinophilic EsophagitisDrug: Budesonide 0.5mg orodispersible tablet twice daily;Drug: Budesonide 1mg orodispersible tablet twice daily;Drug: Placebo orodispersible tablet twice dailyDr. Falk Pharma GmbHNULLActive, not recruiting18 Years75 YearsAll204Phase 3Germany
13EUCTR2014-001485-99-GB
(EUCTR)
23/12/201523/10/2015Double-blind (neither physician nor patient knows of the actual treatment which can with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets in comparison with placebo for maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitisDouble-blind, randomized, placebo-controlled, phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets vs. placebo for maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitis - Maintenance of remission with budesonide effervescent tabl. vs. placebo in eosinophilic esophagitis Maintenance of remission in eosinophilic esophagitis
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: 1 mg budesonide effervescent tablet for orodispersible use
Product Code: BUET 1mg
INN or Proposed INN: BUDESONIDE
Product Name: 0.5 mg budesonide effervescent tablet for orodispersible use
Product Code: BUET 0.5 mg
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
204Phase 3Belgium;Spain;Denmark;Netherlands;Germany;Switzerland;United Kingdom
14EUCTR2014-001484-12-NL
(EUCTR)
23/12/201512/10/2015Double-blind (neither physician nor patient knows of the actual treatment which can with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (tested against tablets without active substance), phase III study on the efficacy and tolerability of a 6-week treatment with budesonide effervescent tablets vs. placebo for induction of clinico-pathological remission in adult patients with active eosinophilic esophagitisDouble-blind, randomized, placebo-controlled, phase III trial on the efficacy and tolerability of a 6-week treatment with budesonide effervescent tablets vs. placebo for induction of clinico-pathological remission in adult patients with active eosinophilic esophagitis - Induction of remission with budesonide effervescent tablets vs. placebo in eosinophilic esophagitis Active eosinophilic esophagitis
MedDRA version: 18.0;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: 1 mg budesonide effervescent tablet for orodispersible use
Product Code: BUET 1mg
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
90Phase 3Spain;Belgium;Germany;Netherlands;Switzerland
15EUCTR2014-001485-99-DE
(EUCTR)
08/12/201529/06/2015Double-blind (neither physician nor patient knows of the actual treatment which can with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets in comparison with placebo for maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitisDouble-blind, randomized, placebo-controlled, phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets vs. placebo for maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitis - Maintenance of remission with budesonide effervescent tabl. vs. placebo in eosinophilic esophagitis Maintenance of remission in eosinophilic esophagitis
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
204 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noBelgium;Spain;Denmark;Netherlands;Germany;United Kingdom;Switzerland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT02605837
(ClinicalTrials.gov)
December 7, 20154/11/2015A Study in Adolescents and Adults With Eosinophilic Esophagitis (EoE) Measuring Histologic Response and Determine if Reduction in Dysphagia is AchievedOral Budesonide Suspension (OBS) in Adolescent and Adult Subjects (11 to 55 Years of Age, Inclusive) With Eosinophilic Esophagitis: A Phase 3 Randomized, Double-blind, Placebo-controlled StudyEosinophilic Esophagitis (EoE)Drug: Oral Budesonide Suspension (OBS);Drug: PlaceboShireNULLCompleted11 Years55 YearsAll318Phase 3United States
17NCT02434029
(ClinicalTrials.gov)
November 11, 201530/4/2015Budesonide Orodispersible Tablet vs. Placebo in Active Eosinophilic EsophagitisDouble-blind, Randomized, Placebo-controlled, Phase III Trial on the Efficacy and Tolerability of a 6-week Treatment With Budesonide Effervescent Tablets vs. Placebo for Induction of Clinico-pathological Remission in Adult Patients With Active Eosinophilic EsophagitisEosinophilic EsophagitisDrug: Budesonide 1mg orodispersible tablet twice daily;Drug: Placebo orodispersible tablet twice dailyDr. Falk Pharma GmbHNULLCompleted18 Years75 YearsAll88Phase 3Germany
18EUCTR2014-001484-12-BE
(EUCTR)
09/10/201519/05/2015Double-blind (neither physician nor patient knows of the actual treatment which can with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (tested against tablets without active substance), phase III study on the efficacy and tolerability of a 6-week treatment with budesonide effervescent tablets vs. placebo for induction of clinico-pathological remission in adult patients with active eosinophilic esophagitisDouble-blind, randomized, placebo-controlled, phase III trial on the efficacy and tolerability of a 6-week treatment with budesonide effervescent tablets vs. placebo for induction of clinico-pathological remission in adult patients with active eosinophilic esophagitis - Induction of remission with budesonide effervescent tablets vs. placebo in eosinophilic esophagitis Active eosinophilic esophagitis
MedDRA version: 18.0;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: 1 mg budesonide effervescent tablet for orodispersible use
Product Code: BUET 1mg
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
90Phase 3Spain;Belgium;Netherlands;Germany;Switzerland
19EUCTR2014-001484-12-DE
(EUCTR)
22/09/201509/04/2015Double-blind (neither physician nor patient knows of the actual treatment which can with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (tested against tablets without active substance), phase III study on the efficacy and tolerability of a 6-week treatment with budesonide effervescent tablets vs. placebo for induction of clinico-pathological remission in adult patients with active eosinophilic esophagitisDouble-blind, randomized, placebo-controlled, phase III trial on the efficacy and tolerability of a 6-week treatment with budesonide effervescent tablets vs. placebo for induction of clinico-pathological remission in adult patients with active eosinophilic esophagitis - Induction of remission with budesonide effervescent tablets vs. placebo in eosinophilic esophagitis Active eosinophilic esophagitis
MedDRA version: 19.0;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: 1 mg budesonide effervescent tablet for orodispersible use
Product Code: BUET 1mg
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
90Phase 3Spain;Belgium;Netherlands;Germany;Switzerland
20EUCTR2014-001484-12-ES
(EUCTR)
18/08/201510/07/2015Double-blind (neither physician nor patient knows of the actual treatment which can with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (tested against tablets without active substance), phase III study on the efficacy and tolerability of a 6-week treatment with budesonide effervescent tablets vs. placebo for induction of clinico-pathological remission in adult patients with active eosinophilic esophagitisDouble-blind, randomized, placebo-controlled, phase III trial on the efficacy and tolerability of a 6-week treatment with budesonide effervescent tablets vs. placebo for induction of clinico-pathological remission in adult patients with active eosinophilic esophagitis - Induction of remission with budesonide effervescent tablets vs. placebo in eosinophilic esophagitis Active eosinophilic esophagitis
MedDRA version: 18.0;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: 1 mg budesonide effervescent tablet for orodispersible use
Product Code: BUET 1mg
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
90Phase 3Belgium;Spain;Netherlands;Germany;Switzerland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT02019758
(ClinicalTrials.gov)
January 1, 201518/12/2013Budesonide Versus Fluticasone for Treatment of Eosinophilic EsophagitisBudesonide Versus Fluticasone for Treatment of Eosinophilic EsophagitisEosinophilic EsophagitisDrug: Oral Viscous Budesonide;Drug: Fluticasone MDI;Drug: Placebo slurry;Drug: Placebo inhalerUniversity of North Carolina, Chapel HillNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed16 Years80 YearsAll129Phase 4United States
22NCT02125851
(ClinicalTrials.gov)
January 201421/2/2014Comparison of Esophageal Clearance Times of Oral Budesonide PreparationsComparison of Esophageal Clearance Times of Oral Budesonide PreparationsEosinophilic EsophagitisOther: Xanthan Gum;Other: HoneyWalter Reed National Military Medical CenterNULLCompleted18 Years75 YearsBoth24N/AUnited States
23NCT01821898
(ClinicalTrials.gov)
July 9, 201327/3/2013Eosinophilic Esophagitis Clinical Therapy Comparison TrialEosinophilic Esophagitis Clinical Therapy Comparison TrialEosinophilic EsophagitisDrug: Oral Budesonide;Other: Elimination dietBaylor College of MedicineNULLTerminated3 Years17 YearsAll5Phase 2United States
24NCT01846962
(ClinicalTrials.gov)
November 201230/4/2013Dietetic Versus Topical Steroids for Pediatric Eosinophilic EsophagitisCOMPARISON OF TREATMENT FOR PEDIATRIC EOSINOPHILIC ESOPHAGITIS: A RANDOMIZED CLINICAL TRIAL (DIETETIC Versus TOPICAL STEROIDS)Eosinophilic EsophagitisDrug: Budesonide;Drug: Fluticasone;Behavioral: six-foods elimination diet;Drug: Oral Viscous Budesonide (OVB)Azienda Policlinico Umberto INULLCompleted6 Months18 YearsAll64Phase 4Italy
25NCT01642212
(ClinicalTrials.gov)
July 23, 201213/7/2012OBS in Adolescent and Adults With EOE: A Phase II, Randomized, Double-Blind, Placebo Controlled, Study With an Open Label ExtensionOral Budesonide Suspension (OBS) in Adolescent and Adult Subjects (11-40 Years of Age)With Eosinophilic Esophagitis: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study With an Open Label ExtensionEosinophilic Esophagitis (EoE)Drug: Oral Budesonide Suspension (MB-9);Drug: PlaceboShireNULLCompleted11 Years40 YearsAll93Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2009-016692-29-BE
(EUCTR)
20/02/201224/11/2011A study to investigate the efficacy and tolerance of budesonide tablets and suspension in patients suffering from esophagitis over a 14 day periodDouble-blind, double-dummy, randomized, placebo-controlled, phase IIa study on the efficacy and tolerability of a 14-day treatment with budesonide effervescent tablets vs. viscous budesonide suspension vs. placebo in patients with eosinophilic esophagitis - Budesonide effervescent tablets vs. viscous budesonide suspension vs. placebo in EE Active eosinophilic esophagitis
MedDRA version: 14.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: 1mg budesonide effervescent tablet for orodispersible use
Product Code: BUET 1mg
INN or Proposed INN: BUDESONIDE
Product Name: 2mg budesonide effervescent tablet for orodispersible use
Product Code: BUET 2mg
INN or Proposed INN: BUDESONIDE
Product Name: Budesonide [0.4mg/ml] viscous suspension
Product Code: BUU 0.4mg/ml
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
100Phase 2Belgium;Germany;Switzerland
27NCT02280616
(ClinicalTrials.gov)
June 201129/10/2014Budesonide Effervescent Tablets vs. Viscous Budesonide Suspension vs. Placebo in Eosinophilic EsophagitisDouble-blind, Double-dummy, Randomized, Placebo-controlled, Phase IIa Study on the Efficacy and Tolerability of a 14-day Treatment With Budesonide Effervescent Tablets vs. Viscous Budesonide Suspension vs. Placebo in Patients With Eosinophilic EsophagitisEosinophilic EsophagitisDrug: low dose budesonide tablet;Drug: high dose budesonide tablet;Drug: high dose budesonide suspension;Drug: PlaceboDr. Falk Pharma GmbHNULLCompleted18 Years75 YearsBoth76Phase 2Germany
28NCT00961233
(ClinicalTrials.gov)
October 200914/8/2009Topical Budesonide Treatment for Eosinophilic Esophagitis (EoE)Topical Budesonide Treatment for Eosinophilic Esophagitis (EoE): Esophageal Medication Distribution, Treatment Response, and Effect on the Adrenal Axis.Eosinophilic EsophagitisDrug: inhaled/swallowed budesonide;Drug: viscous/swallowed budesonideUniversity of North Carolina, Chapel HillAstraZenecaCompleted18 YearsN/AAll25N/AUnited States
29NCT00762073
(ClinicalTrials.gov)
November 200829/9/2008Dose-Ranging Study of Oral Viscous Budesonide in Pediatrics With Eosinophilic EsophagitisOral Viscous Budesonide Suspension (MB-7) in Subjects With Eosinophilic Esophagitis: A Randomized, Placebo-Controlled, Dose-Ranging Study in Children and AdolescentsEosinophilic Esophagitis (EoE)Drug: budesonide;Drug: placeboShireNULLCompleted2 Years18 YearsAll82Phase 2United States
30NCT00728481
(ClinicalTrials.gov)
May 200815/7/2008The Role Of Gastroesophageal Reflux Disease (GERD) in Eosinophilic EsophagitisThe Role Of Gastroesophageal Reflux Disease (GERD) in Eosinophilic EsophagitisEosinophilic Esophagitis;Gastroesophageal Reflux Disease;EE;GERDDrug: Esomeprazole;Drug: BudesonideMayo ClinicAstraZenecaCompleted18 Years80 YearsAll51Phase 2/Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31NCT00638456
(ClinicalTrials.gov)
February 200812/3/2008Use of Topical Budesonide in the Treatment of Eosinophilic EsophagitisUse of Topical Budesonide in the Treatment of Eosinophilic Esophagitis, a Randomized Clinical TrialEosinophilic EsophagitisDrug: Budesonide plus Prevacid;Drug: placebo plus PrevacidRanjan DohilMeritage Pharma, Inc.Completed1 YearN/AAll32Phase 2United States
32NCT00271349
(ClinicalTrials.gov)
December 200529/12/2005Budesonide for Eosinophilic EsophagitisBudesonide for Eosinophilic Esophagitis: a Randomized, Placebo-controlled, Double-blind Treatment StudyEosinophilic EsophagitisDrug: BudesonideSwiss EE Study GroupNULLCompleted14 Years70 YearsBoth28Phase 2Switzerland
33EUCTR2014-002465-30-IT
(EUCTR)
24/06/2014Spontaneous study on the efficacy and safety of an oral viscous suspension of budesonide administered to children affected by eosinophilic esophagitis.Spontaneous study on the efficacy and safety of an oral viscous suspension of budesonide administered to children affected by eosinophilic esophagitis. Eosinophilic Esophagitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Product Name: Budesonide
Product Code: Budesonide
INN or Proposed INN: BUDESONIDE
Dip. Pediatria UOC Gastroenterologia ed Epatologia PediatricaNULLNAFemale: yes
Male: yes
Phase 2Italy
34EUCTR2017-003737-29-DE
(EUCTR)
17/12/2018Double-blind (neither physician nor patient knows of the actual treatment which can be with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (one of the treatment groups receives medication without active substance), phase II/III study on the efficacy and tolerability of oral budesonide suspension in comparison with placebo in children and adolescents with eosinophilic esophagitisDouble-blind, randomized, placebo-controlled, Phase II/III trial on the efficacy and tolerability of treatment with budesonide oral suspension vs. placebo in children and adolescents with eosinophilic esophagitis - Budesonide oral suspension vs. placebo in pediatric eosinophilic esophagitis Active eosinophilic esophagitis and maintenance of remission in eosinophilic esophagitis
MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
75 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;Greece;Spain;Israel;Netherlands;Germany;United Kingdom

228. 閉塞性細気管支炎 [臨床試験数:92,薬物数:125(DrugBank:34),標的遺伝子数:33,標的パスウェイ数:152
Searched query = "Bronchiolitis obliterans", "Obliterating bronchiolitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
2 / 92 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01560689
(ClinicalTrials.gov)
June 200820/3/2012Inhaled BUDESONIDE/FORMOTEROL in Bronchiolitis Obliterans Following Stem Cell TransplantationOpen-labeled Trial to Evaluate the Therapeutic Effects of Inhaled BUDESONIDE/FORMOTEROL in Bronchiolitis Obliterans After Allogeneic Stem Cell TransplantationBronchiolitis Obliterans;Allogeneic Stem Cell TransplantationDrug: Budesonide/formoterol;Drug: PlaceboAssistance Publique - Hôpitaux de ParisNULLCompleted16 YearsN/ABoth32Phase 2France
2NCT00624754
(ClinicalTrials.gov)
March 200815/2/2008Prospective Evaluation of the Efficacy of Budesonide/Formoterol in Bronchiolitis Obliterans in AHSCTrecipientsProspective Evaluation of the Efficacy of Budesonide/Formoterol (Symbicort®) in Bronchiolitis Obliterans in Allogeneic Haematopoietic Stem Cell Transplantation (AHSCT) RecipientsObstructive Airway DiseaseDrug: Formoterol/Budesonide;Drug: lactoseAssistance Publique - Hôpitaux de ParisAstraZenecaCompleted16 YearsN/ABoth32Phase 2France

299. 嚢胞性線維症 [臨床試験数:1,592,薬物数:1,539(DrugBank:255),標的遺伝子数:81,標的パスウェイ数:162
Searched query = "Cystic fibrosis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
1 / 1,592 trial found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00728715
(ClinicalTrials.gov)
January 200431/7/2008Efficacy of Budesonide-Formoterol in BronchiectasisClinical Efficacy and Safety of Budesonide and Formoterol in the Management of Non-Cystic Fibrosis BronchiectasisBronchiectasisDrug: budesonide-formoterol single inhaler;Drug: High dose of budesonide;Drug: A;Drug: BHospital General de RequenaEsteve Labs (Grant)Completed18 Years80 YearsBoth40N/ASpain