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.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
34 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_
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registration
Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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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