Budenofalk 9mg gastro-resistant granules ( DrugBank: - )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 96 | クローン病 | 7 |
96. クローン病
臨床試験数 : 2,400 / 薬物数 : 1,391 - (DrugBank : 267) / 標的遺伝子数 : 170 - 標的パスウェイ数 : 215
| 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 | EUCTR2008-006957-42-BG (EUCTR) | 17/11/2009 | 21/08/2009 | Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s disease | Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s disease | Induction of remission in active Crohn´s disease MedDRA version: 12.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode MedDRA version: 12.0;Level: PT;Classification code 10011401;Term: Crohn's disease | Product Name: Budenofalk 9mg gastro-resistant granules Product Code: Budenofalk 9mg gastro-resistant granules INN or Proposed INN: BUDESONIDE Trade Name: Budenofalk 3mg gastro-resistant capsules Product Name: Budenofalk 3mg gastro-resistant capsules INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Hungary;Slovakia;Czech Republic;Germany;Bulgaria;Latvia;Lithuania | ||
| 2 | EUCTR2008-006957-42-DE (EUCTR) | 30/10/2009 | 30/07/2009 | Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s disease | Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s disease | Induction of remission in active Crohn´s disease MedDRA version: 14.1;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders | Product Name: Budenofalk 9mg gastro-resistant granules Product Code: Budenofalk 9mg gastro-resistant granules INN or Proposed INN: BUDESONIDE Trade Name: Budenofalk 3mg gastro-resistant capsules Product Name: Budenofalk 3mg gastro-resistant capsules INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Hungary;Czech Republic;Slovakia;Ukraine;Romania;Lithuania;Russian Federation;Bulgaria;Latvia;Germany | ||
| 3 | EUCTR2008-006957-42-LT (EUCTR) | 19/10/2009 | 12/08/2009 | Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s disease | Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s disease | Induction of remission in active Crohn´s disease MedDRA version: 14.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders | Product Name: Budenofalk 9mg gastro-resistant granules Product Code: Budenofalk 9mg gastro-resistant granules INN or Proposed INN: BUDESONIDE Trade Name: Budenofalk 3mg gastro-resistant capsules Product Name: Budenofalk 3mg gastro-resistant capsules INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Hungary;Germany;Czech Republic;Slovakia;Russian Federation;Ukraine;Bulgaria;Romania;Latvia;Lithuania | ||
| 4 | EUCTR2008-006957-42-SK (EUCTR) | 14/10/2009 | 19/10/2009 | Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s disease | Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s disease | Induction of remission in active Crohn´s disease MedDRA version: 12.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode MedDRA version: 12.0;Level: PT;Classification code 10011401;Term: Crohn's disease | Product Name: Budenofalk 9mg gastro-resistant granules Product Code: Budenofalk 9mg gastro-resistant granules INN or Proposed INN: BUDESONIDE Trade Name: Budenofalk 3mg gastro-resistant capsules Product Name: Budenofalk 3mg gastro-resistant capsules INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Czech Republic;Hungary;Slovakia;Lithuania;Bulgaria;Latvia;Germany | ||
| 5 | EUCTR2008-006957-42-LV (EUCTR) | 25/09/2009 | 08/09/2009 | Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s disease | Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s disease | Induction of remission in active Crohn´s disease MedDRA version: 14.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders | Product Name: Budenofalk 9mg gastro-resistant granules Product Code: Budenofalk 9mg gastro-resistant granules INN or Proposed INN: BUDESONIDE Trade Name: Budenofalk 3mg gastro-resistant capsules Product Name: Budenofalk 3mg gastro-resistant capsules INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Czech Republic;Hungary;Slovakia;Lithuania;Bulgaria;Germany;Latvia | ||
| 6 | EUCTR2008-006957-42-CZ (EUCTR) | 24/09/2009 | 07/09/2009 | Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s disease | Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s disease | Induction of remission in active Crohn´s disease MedDRA version: 12.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode MedDRA version: 12.0;Level: PT;Classification code 10011401;Term: Crohn's disease | Product Name: Budenofalk 9mg gastro-resistant granules Product Code: Budenofalk 9mg gastro-resistant granules INN or Proposed INN: BUDESONIDE Trade Name: Budenofalk 3mg gastro-resistant capsules Product Name: Budenofalk 3mg gastro-resistant capsules INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Hungary;Slovakia;Germany;Czech Republic;Bulgaria;Latvia;Lithuania | ||
| 7 | EUCTR2008-006957-42-HU (EUCTR) | 16/09/2009 | 04/08/2009 | Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s disease | Double-blind, double-dummy, randomised, comparative, multi-centre phase III study on the efficacy and tolerability of an 8-week oral treatment with 9 mg budesonide once daily vs. 3 mg budesonide three-times daily in patients with active Crohn’s disease - 9 mg budesonide OD vs. 3 mg budesonide TID in active Crohn’s disease | Induction of remission in active Crohn´s disease MedDRA version: 12.0;Level: LLT;Classification code 10058815;Term: Crohn's disease acute episode MedDRA version: 12.0;Level: PT;Classification code 10011401;Term: Crohn's disease | Product Name: Budenofalk 9mg gastro-resistant granules Product Code: Budenofalk 9mg gastro-resistant granules INN or Proposed INN: BUDESONIDE Trade Name: Budenofalk 3mg gastro-resistant capsules Product Name: Budenofalk 3mg gastro-resistant capsules INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Hungary;Slovakia;Czech Republic;Germany;Bulgaria;Latvia;Lithuania |