97. 潰瘍性大腸炎 Ulcerative colitis Clinical trials / Disease details
臨床試験数 : 2,527 / 薬物数 : 1,465 - (DrugBank : 259) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
| 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 | EUCTR2017-004576-57-PL (EUCTR) | 18/05/2019 | 01/08/2019 | Novel budesonide capsules vs. budesonide tabltes in patients with ulcerative colitis refractory to standard treatment with mesalazine | Randomised, double-blind, double-dummy, active-controlled, phase III clinical trial on the efficacy and safety of an 8-week add-on treatment with budesonide 9 mg capsules vs. budesonide 6 mg capsules vs. budesonide-MMX® 9 mg tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine - TOPICAL-2 | Patients with active ulcerative colitis refractory to standard treatment with mesalazine MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide 9 mg prolonged-release capsules, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Product Name: Budesonide 6 mg prolonged-release capsules, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Trade Name: CortimentMMX 9 mg INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 777 | Phase 3 | Serbia;Czechia;Czech Republic;Hungary;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany | ||
| 2 | EUCTR2017-004576-57-DE (EUCTR) | 26/04/2019 | 08/01/2019 | Novel budesonide capsules vs. budesonide tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine | Randomised, double-blind, double-dummy, active-controlled, phase III clinical trial on the efficacy and safety of an 8-week add-on treatment with budesonide 9 mg capsules vs. budesonide 6 mg capsules vs. budesonide-MMX® 9 mg tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine - TOPICAL-2 | Patients with active ulcerative colitis refractory to standard treatment with mesalazine MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide 9 mg prolonged-release capsule, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Product Name: Budesonide 6 mg prolonged-release capsule, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Trade Name: CortimentMMX 9 mg INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 777 | Phase 3 | Serbia;Czechia;Czech Republic;Hungary;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany | ||
| 3 | EUCTR2017-004576-57-LV (EUCTR) | 15/04/2019 | 14/01/2019 | Novel budesonide capsules vs. budesonide tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine | Randomised, double-blind, double-dummy, active-controlled, phase III clinical trial on the efficacy and safety of an 8-week add-on treatment with budesonide 9 mg capsules vs. budesonide 6 mg capsules vs. budesonide-MMX® 9 mg tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine - TOPICAL-2 | Patients with active ulcerative colitis refractory to standard treatment with mesalazine MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide 9 mg prolonged-release capsule, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Product Name: Budesonide 6 mg prolonged-release capsule, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Trade Name: CortimentMMX 9 mg INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 777 | Phase 3 | Serbia;Czechia;Czech Republic;Hungary;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Germany;Latvia | ||
| 4 | EUCTR2017-004576-57-CZ (EUCTR) | 27/03/2019 | 15/03/2019 | Novel budesonide capsules vs. budesonide tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine | Randomised, double-blind, double-dummy, active-controlled, phase III clinical trial on the efficacy and safety of an 8-week add-on treatment with budesonide 9 mg capsules vs. budesonide 6 mg capsules vs. budesonide-MMX® 9 mg tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine - TOPICAL-2 | Patients with active ulcerative colitis refractory to standard treatment with mesalazine MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide 9 mg prolonged-release capsules, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Product Name: Budesonide 6 mg prolonged-release capsules, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Trade Name: CortimentMMX 9 mg INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 777 | Phase 3 | Serbia;Czechia;Hungary;Czech Republic;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany | ||
| 5 | EUCTR2017-004576-57-LT (EUCTR) | 15/03/2019 | 29/01/2019 | Novel budesonide capsules vs. budesonide tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine | Randomised, double-blind, double-dummy, active-controlled, phase III clinical trial on the efficacy and safety of an 8-week add-on treatment with budesonide 9 mg capsules vs. budesonide 6 mg capsules vs. budesonide-MMX® 9 mg tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine - TOPICAL-2 | Patients with active ulcerative colitis refractory to standard treatment with mesalazine MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide 9 mg prolonged-release capsule, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Product Name: Budesonide 6 mg prolonged-release capsule, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Trade Name: CortimentMMX 9 mg INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 777 | Phase 3 | Serbia;Czechia;Czech Republic;Hungary;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany | ||
| 6 | EUCTR2017-004576-57-SK (EUCTR) | 12/03/2019 | 18/01/2019 | Novel budesonide capsules vs. budesonide tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine | Randomised, double-blind, double-dummy, active-controlled, phase III clinical trial on the efficacy and safety of an 8-week add-on treatment with budesonide 9 mg capsules vs. budesonide 6 mg capsules vs. budesonide-MMX® 9 mg tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine - TOPICAL-2 | Patients with active ulcerative colitis refractory to standard treatment with mesalazine MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide 9 mg prolonged-release capsules, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Product Name: Budesonide 6 mg prolonged-release capsules, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Trade Name: CortimentMMX 9 mg INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 777 | Phase 3 | Germany;Latvia;Russian Federation;Lithuania;Ukraine;Poland;Slovakia;Hungary;Czech Republic;Czechia;Serbia | ||
| 7 | EUCTR2017-004576-57-HU (EUCTR) | 11/03/2019 | 16/01/2019 | Novel budesonide capsules vs. budesonide tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine | Randomised, double-blind, double-dummy, active-controlled, phase III clinical trial on the efficacy and safety of an 8-week add-on treatment with budesonide 9 mg capsules vs. budesonide 6 mg capsules vs. budesonide-MMX® 9 mg tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine - TOPICAL-2 | Patients with active ulcerative colitis refractory to standard treatment with mesalazine MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide 9 mg prolonged-release capsules, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Product Name: Budesonide 6 mg prolonged-release capsules, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Trade Name: CortimentMMX 9 mg INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 777 | Phase 3 | Czech Republic;Hungary;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany |