Oral Budesonide ( DrugBank: Budesonide )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
98好酸球性消化管疾患10

98. 好酸球性消化管疾患


臨床試験数 : 172 薬物数 : 149 - (DrugBank : 39) / 標的遺伝子数 : 38 - 標的パスウェイ数 : 135
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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]
Product Name: Budesonide oral suspension [0.2 mg/ml]
INN or Proposed INN: BUDESONIDE
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
75Phase 2;Phase 3Portugal;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]
Product Name: Budesonide oral suspension [0.2 mg/ml]
INN or Proposed INN: BUDESONIDE
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]
Product Name: Budesonide oral suspension [0.2 mg/ml]
INN or Proposed INN: BUDESONIDE
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
6NCT02736409
(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
7NCT02605837
(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
8NCT01821898
(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
9NCT01642212
(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
10EUCTR2017-003737-29-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]
Product Name: Budesonide oral suspension [0.2 mg/ml]
INN or Proposed INN: BUDESONIDE
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