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 | EUCTR2020-001314-37-AT (EUCTR) | 06/05/2021 | 01/03/2021 | clinical study to show equal clinical efficacy of two dosing regimen of budesonid orodispersible tablets (twice daily vs. once daily) for treatment of inflammation of the esophagus | Double-blind, double-dummy, randomized, parallel-group, non-inferiority phase III trial on the efficacy and tolerability of 2 mg once daily vs. 1 mg twice daily budesonide orodispersible tablets for induction of histological remission in adults with eosinophilic esophagitis | eosinophilic esophagitis MedDRA version: 20.1;Level: PT;Classification code 10064212;Term: Eosinophilic oesophagitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide 2 mg orodispersible tablets (BUL 2 mg) INN or Proposed INN: BUDESONIDE Trade Name: Jorveza Product Name: Budesonide 1 mg orodispersible tablets (BUL 1 mg) INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 242 | Phase 3 | Portugal;Canada;Spain;Austria;Russian Federation;Germany;Switzerland | ||
| 2 | EUCTR2020-001314-37-DE (EUCTR) | 26/04/2021 | 27/11/2020 | clinical study to show equal clinical efficacy of two dosing regimen of budesonid orodispersible tablets (twice daily vs. once daily) for treatment of inflammation of the esophagus | Double-blind, double-dummy, randomized, parallel-group, non-inferiority phase III trial on the efficacy and tolerability of 2 mg once daily vs. 1 mg twice daily budesonide orodispersible tablets for induction of histological remission in adults with eosinophilic esophagitis | eosinophilic esophagitis MedDRA version: 20.1;Level: PT;Classification code 10064212;Term: Eosinophilic oesophagitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide 2 mg orodispersible tablets (BUL 2 mg) INN or Proposed INN: BUDESONIDE Trade Name: Jorveza Product Name: Budesonide 1 mg orodispersible tablets (BUL 1 mg) INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 242 | Phase 3 | Portugal;Canada;Spain;Austria;Russian Federation;Germany;Switzerland |