98. 好酸球性消化管疾患 Eosinophilic gastrointestinal disease Clinical trials / Disease details
臨床試験数 : 171 / 薬物数 : 184 - (DrugBank : 47) / 標的遺伝子数 : 42 - 標的パスウェイ数 : 141
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2017-003737-29-NL (EUCTR) | 01/04/2020 | 09/04/2019 | Double-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 esophagitis | Double-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 GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2;Phase 3 | Portugal;Greece;Spain;Israel;Germany;Netherlands;United Kingdom | ||
| 2 | EUCTR2017-003737-29-GR (EUCTR) | 18/09/2019 | 03/09/2019 | Double-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 esophagitis | Double-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 GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2;Phase 3 | Portugal;Greece;Spain;Israel;Netherlands;Germany;United Kingdom | ||
| 3 | EUCTR2017-003737-29-GB (EUCTR) | 01/08/2019 | 24/10/2019 | Double-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 esophagitis | Double-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 GmbH | NULL | Authorised-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): no | Portugal;Greece;Spain;Israel;Netherlands;Germany;United Kingdom | ||
| 4 | EUCTR2017-003737-29-PT (EUCTR) | 24/05/2019 | 29/01/2019 | Double-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 esophagitis | Double-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 GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2;Phase 3 | Portugal;Greece;Spain;Israel;Netherlands;Germany;United Kingdom | ||
| 5 | EUCTR2017-003737-29-ES (EUCTR) | 11/04/2019 | 18/01/2019 | Double-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 esophagitis | Double-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 GmbH | NULL | Authorised-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): no | Portugal;Greece;Spain;Israel;Netherlands;Germany;United Kingdom | ||
| 6 | NCT02736409 (ClinicalTrials.gov) | April 29, 2016 | 22/3/2016 | An 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: Placebo | Shire | NULL | Completed | 11 Years | 55 Years | All | 200 | Phase 3 | United States;United Kingdom |
| 7 | NCT02605837 (ClinicalTrials.gov) | December 7, 2015 | 4/11/2015 | A Study in Adolescents and Adults With Eosinophilic Esophagitis (EoE) Measuring Histologic Response and Determine if Reduction in Dysphagia is Achieved | Oral 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 Study | Eosinophilic Esophagitis (EoE) | Drug: Oral Budesonide Suspension (OBS);Drug: Placebo | Shire | NULL | Completed | 11 Years | 55 Years | All | 318 | Phase 3 | United States |
| 8 | NCT02125851 (ClinicalTrials.gov) | January 2014 | 21/2/2014 | Comparison of Esophageal Clearance Times of Oral Budesonide Preparations | Comparison of Esophageal Clearance Times of Oral Budesonide Preparations | Eosinophilic Esophagitis | Other: Xanthan Gum;Other: Honey | Walter Reed National Military Medical Center | NULL | Completed | 18 Years | 75 Years | Both | 24 | N/A | United States |
| 9 | NCT01821898 (ClinicalTrials.gov) | July 9, 2013 | 27/3/2013 | Eosinophilic Esophagitis Clinical Therapy Comparison Trial | Eosinophilic Esophagitis Clinical Therapy Comparison Trial | Eosinophilic Esophagitis | Drug: Oral Budesonide;Other: Elimination diet | Baylor College of Medicine | NULL | Terminated | 3 Years | 17 Years | All | 5 | Phase 2 | United States |
| 10 | NCT01642212 (ClinicalTrials.gov) | July 23, 2012 | 13/7/2012 | OBS in Adolescent and Adults With EOE: A Phase II, Randomized, Double-Blind, Placebo Controlled, Study With an Open Label Extension | Oral 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 Extension | Eosinophilic Esophagitis (EoE) | Drug: Oral Budesonide Suspension (MB-9);Drug: Placebo | Shire | NULL | Completed | 11 Years | 40 Years | All | 93 | Phase 2 | United States |
| 11 | EUCTR2017-003737-29-DE (EUCTR) | 17/12/2018 | Double-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 esophagitis | Double-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 GmbH | NULL | Authorised-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): no | Portugal;Greece;Spain;Israel;Netherlands;Germany;United Kingdom |