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 | EUCTR2017-003516-39-ES (EUCTR) | 22/07/2021 | 14/06/2021 | A phase III clinical study in adult and adolescent patients with eosinophilic inflammation of the gullet to prove superiority compared to placebo of an episodic and/or a continuous 48-week treatment with budesonide orodispersible tablets for maintaining remission | Double-blind, randomized phase III trial in adult and adolescent patients with eosinophilic esophagitis to prove superiority compared to placebo of an episodic and/or a continuous 48-week treatment with budesonide orodispersible tablets for maintaining clinico-histological remission | 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] | Trade Name: Jorveza 1 mg orodispersible tablets Product Name: Budesonide 1 mg orodispersible tablets Product Code: BUL 1 mg INN or Proposed INN: BUDESONIDE Trade Name: Jorveza 0.5 mg orodispersible tablets Product Name: Budesonide 0.5 mg orodispersible tablets Product Code: BUL 0.5 mg INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 110 | Phase 3 | Spain;Germany;Switzerland;Italy | ||
| 2 | EUCTR2017-003516-39-DE (EUCTR) | 28/04/2021 | 21/12/2020 | A phase III clinical study in adult and adolescent patients with eosinophilic inflammation of the gullet to prove superiority compared to placebo of an episodic and/or a continuous 48-week treatment with budesonide orodispersible tablets for maintaining remission | Double-blind, randomized phase III trial in adult and adolescent patients with eosinophilic esophagitis to prove superiority compared to placebo of an episodic and/or a continuous 48-week treatment with budesonide orodispersible tablets for maintaining clinico-histological remission | 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] | Trade Name: Jorveza 1 mg orodispersible tablets Product Name: Budesonide 1 mg orodispersible tablets Product Code: BUL 1 mg INN or Proposed INN: BUDESONIDE Trade Name: Jorveza 0.5 mg orodispersible tablets Product Name: Budesonide 0.5 mg orodispersible tablets Product Code: BUL 0.5 mg INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 110 | Phase 3 | Spain;Germany;Switzerland;Italy |