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.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
50 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