93. 原発性胆汁性胆管炎 Primary biliary cholangitis Clinical trials / Disease details
臨床試験数 : 282 / 薬物数 : 245 - (DrugBank : 56) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 113
| 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 | EUCTR2008-001524-31-NL (EUCTR) | 26/11/2008 | 17/07/2008 | Double-blind, double-dummy, randomized, crossover, multicentre phase IV clinical study comparing the effect of Ursofalk® 500 mg tablets od versus Ursofalk® 250 mg capsules od on liver enzyme parameters in the treatment of primary biliary cirrhosis - Ursofalk® tablets versus Ursofalk® capsules in the treatment of PBC | Double-blind, double-dummy, randomized, crossover, multicentre phase IV clinical study comparing the effect of Ursofalk® 500 mg tablets od versus Ursofalk® 250 mg capsules od on liver enzyme parameters in the treatment of primary biliary cirrhosis - Ursofalk® tablets versus Ursofalk® capsules in the treatment of PBC | Treatment of primary biliary cirrhosis MedDRA version: 9.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis | Trade Name: Ursofalk® capsules INN or Proposed INN: URSODEOXYCHOLIC ACID Trade Name: Ursofalk® 500 mg film-coated tablets INN or Proposed INN: URSODEOXYCHOLIC ACID | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 74 | Phase 4 | Germany;Netherlands | ||
| 2 | EUCTR2008-001524-31-DE (EUCTR) | 26/08/2008 | 11/07/2008 | Double-blind, double-dummy, randomized, crossover, multicentre phase IV clinical study comparing the effect of Ursofalk® 500 mg tablets od versus Ursofalk® 250 mg capsules od on liver enzyme parameters in the treatment of primary biliary cirrhosis - Ursofalk® tablets versus Ursofalk® capsules in the treatment of PBC | Double-blind, double-dummy, randomized, crossover, multicentre phase IV clinical study comparing the effect of Ursofalk® 500 mg tablets od versus Ursofalk® 250 mg capsules od on liver enzyme parameters in the treatment of primary biliary cirrhosis - Ursofalk® tablets versus Ursofalk® capsules in the treatment of PBC | Treatment of primary biliary cirrhosis MedDRA version: 9.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis | Trade Name: Ursofalk® capsules INN or Proposed INN: URSODEOXYCHOLIC ACID Trade Name: Ursofalk® 500 mg film-coated tablets INN or Proposed INN: URSODEOXYCHOLIC ACID | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 74 | Phase 4 | Germany;Netherlands |