BUL 1 mg ( DrugBank: - )
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 | 5 |
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
| 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-IT (EUCTR) | 09/07/2021 | 17/08/2021 | 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 - Episodic and continuous treatment with budesonide orodispersible tablets versus placebo for maintena | 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 compresse orodispersibili Product Name: Budesonide 1 mg compresse orodispersibili Product Code: [BUL 1 mg] INN or Proposed INN: BUDESONIDE Trade Name: Jorveza 0.5 mg compresse orodispersibili Product Name: Budesonide 0.5 mg compresse orodispersibili 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 | ||
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 |