94. 原発性硬化性胆管炎 Primary sclerosing cholangitis Clinical trials / Disease details
臨床試験数 : 142 / 薬物数 : 113 - (DrugBank : 37) / 標的遺伝子数 : 19 - 標的パスウェイ数 : 139
| 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 | EUCTR2016-003367-19-NL (EUCTR) | 22/01/2019 | 06/02/2018 | A study to compare norursodeoxycholic acid with placebo in the treatment of primary sclerosing cholangitis | Double-blind, randomized, placebo-controlled, phase III study comparing norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis | Primary Sclerosing Cholangitis (PSC) is a slowly progressing chronic cholestatic liver disease of assumed autoimmune, but finally unidentified etiology, characterized by a chronic inflammatory and fibro-obliterative destruction of extra-, and intrahepatic bile ducts. The disease is characterized by diffuse inflammation, fibrosis, and strictures of the intra- and/or extrahepatic bile ducts with an impaired biliary secretion of potentially aggressive bile fluid often leading to cirrhosis. MedDRA version: 20.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Norursodeoxycholic acid INN or Proposed INN: Norursodeoxycholic acid Other descriptive name: NorUDCA | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Finland;Ireland;Lithuania;Austria;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Netherlands;Germany;Sweden | ||
| 2 | EUCTR2016-003367-19-PL (EUCTR) | 20/11/2018 | 28/05/2018 | A study to compare norursodeoxycholic acid with placebo in the treatment of primary sclerosing cholangitis | Double-blind, randomized, placebo-controlled, phase III study comparing norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis - norUDCA vs. Placebo in PSC | Primary Sclerosing Cholangitis (PSC) is a slowly progressing chronic cholestatic liver disease of assumed autoimmune, but finally unidentified etiology, characterized by a chronic inflammatory and fibro-obliterative destruction of extra-, and intrahepatic bile ducts. The disease is characterized by diffuse inflammation, fibrosis, and strictures of the intra- and/or extrahepatic bile ducts with an impaired biliary secretion of potentially aggressive bile fluid often leading to cirrhosis. MedDRA version: 20.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Norursodeoxycholic acid INN or Proposed INN: Norursodeoxycholic acid Other descriptive name: NorUDCA | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | Czechia;Finland;Spain;Ireland;Lithuania;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Norway;Germany;Netherlands;Sweden | ||
| 3 | EUCTR2016-003367-19-IT (EUCTR) | 22/10/2018 | 05/01/2021 | A study to compare norursodeoxycholic acid with placebo in the treatment of primary sclerosing cholangitis | Double-blind, randomized, placebo-controlled, phase III study comparing norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis - NUC-5/PSC | Primary Sclerosing Cholangitis (PSC) is a slowly progressing chronic cholestatic liver disease of assumed autoimmune, but finally unidentified etiology, characterized by a chronic inflammatory and fibro-obliterative destruction of extra-, and intrahepatic bile ducts. The disease is characterized by diffuse inflammation, fibrosis, and strictures of the intra- and/or extrahepatic bile ducts with an impaired biliary secretion of potentially aggressive bile fluid often leading to cirrhosis. MedDRA version: 20.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Norursodeoxycholic acid Product Code: [NorUDCA] INN or Proposed INN: ACIDO DEOSSICOLICO Other descriptive name: NorUDCA (Norursodeoxycholic acid) | DR. FALK PHARMA GMBH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | Finland;Ireland;Lithuania;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Norway;Germany;Netherlands;Sweden | ||
| 4 | EUCTR2016-003367-19-FR (EUCTR) | 06/04/2018 | 08/02/2018 | A study to compare norursodeoxycholic acid with placebo in the treatment of primary sclerosing cholangitis | Double-blind, randomized, placebo-controlled, phase III study comparing norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis | Primary Sclerosing Cholangitis (PSC) is a slowly progressing chronic cholestatic liver disease of assumed autoimmune, but finally unidentified etiology, characterized by a chronic inflammatory and fibro-obliterative destruction of extra-, and intrahepatic bile ducts. The disease is characterized by diffuse inflammation, fibrosis, and strictures of the intra- and/or extrahepatic bile ducts with an impaired biliary secretion of potentially aggressive bile fluid often leading to cirrhosis. MedDRA version: 20.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Norursodeoxycholic acid INN or Proposed INN: Norursodeoxycholic acid Other descriptive name: NorUDCA | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Finland;Ireland;Lithuania;Austria;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands;Sweden | ||
| 5 | EUCTR2016-003367-19-GB (EUCTR) | 12/02/2018 | 21/07/2017 | A study to compare norursodeoxycholic acid with placebo in the treatment of primary sclerosing cholangitis | Double-blind, randomized, placebo-controlled, phase III study comparing norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis | Primary Sclerosing Cholangitis (PSC) is a slowly progressing chronic cholestatic liver disease of assumed autoimmune, but finally unidentified etiology, characterized by a chronic inflammatory and fibro-obliterative destruction of extra-, and intrahepatic bile ducts. The disease is characterized by diffuse inflammation, fibrosis, and strictures of the intra- and/or extrahepatic bile ducts with an impaired biliary secretion of potentially aggressive bile fluid often leading to cirrhosis. MedDRA version: 20.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Norursodeoxycholic acid INN or Proposed INN: Norursodeoxycholic acid Other descriptive name: NorUDCA | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | Czechia;Finland;Spain;Ireland;Lithuania;Austria;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 6 | EUCTR2016-003367-19-LT (EUCTR) | 29/12/2017 | 04/12/2017 | A study to compare norursodeoxycholic acid with placebo in the treatment of primary sclerosing cholangitis | Double-blind, randomized, placebo-controlled, phase III study comparing norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis | Primary Sclerosing Cholangitis (PSC) is a slowly progressing chronic cholestatic liver disease of assumed autoimmune, but finally unidentified etiology, characterized by a chronic inflammatory and fibro-obliterative destruction of extra-, and intrahepatic bile ducts. The disease is characterized by diffuse inflammation, fibrosis, and strictures of the intra- and/or extrahepatic bile ducts with an impaired biliary secretion of potentially aggressive bile fluid often leading to cirrhosis. MedDRA version: 20.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Norursodeoxycholic acid INN or Proposed INN: Norursodeoxycholic acid Other descriptive name: NorUDCA | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | Czechia;Finland;Spain;Ireland;Lithuania;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Belgium;Poland;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 7 | EUCTR2016-003367-19-HU (EUCTR) | 05/10/2017 | 22/08/2017 | A study to compare norursodeoxycholic acid with placebo in the treatment of primary sclerosing cholangitis | Double-blind, randomized, placebo-controlled, phase III study comparing norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis | Primary Sclerosing Cholangitis (PSC) is a slowly progressing chronic cholestatic liver disease of assumed autoimmune, but finally unidentified etiology, characterized by a chronic inflammatory and fibro-obliterative destruction of extra-, and intrahepatic bile ducts. The disease is characterized by diffuse inflammation, fibrosis, and strictures of the intra- and/or extrahepatic bile ducts with an impaired biliary secretion of potentially aggressive bile fluid often leading to cirrhosis. MedDRA version: 20.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Norursodeoxycholic acid INN or Proposed INN: Norursodeoxycholic acid Other descriptive name: NorUDCA | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | Finland;Spain;Ireland;Lithuania;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 8 | EUCTR2011-002754-31-BE (EUCTR) | 13/11/2014 | 04/07/2014 | Double-blind (neither physician nor patient knows of the actual treatment which can be with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (tested against capsules without active substance), phase II dose-finding study comparing different doses of norursodeoxycholic acid capsules with placebo (without active substance) in the treatment of PSC (inflammation of the bile ducts with scar formation) | Double-blind, randomized, placebo-controlled, phase II dose-finding study comparing different doses of norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis - Norursodeoxycholic acid vs. Placebo in PSC | primary sclerosing cholangitis MedDRA version: 17.0;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: norursodeoxycholic acid INN or Proposed INN: norursodeoxycholic acid Other descriptive name: NorUDCA | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | Hungary;Finland;Spain;Belgium;Lithuania;Denmark;Austria;Norway;Netherlands;Germany;United Kingdom;Sweden | ||
| 9 | EUCTR2011-002754-31-GB (EUCTR) | 27/03/2013 | 16/07/2012 | Double-blind (neither physician nor patient knows of the actual treatment which can be with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (tested against capsules without active substance), phase II dose-finding study comparing different doses of norursodeoxycholic acid capsules with placebo (without active substance) in the treatment of PSC (inflammation of the bile ducts with scar formation) | Double-blind, randomized, placebo-controlled, phase II dose-finding study comparing different doses of norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis - Norursodeoxycholic acid vs. Placebo in PSC | primary sclerosing cholangitis MedDRA version: 14.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: norursodeoxycholic acid INN or Proposed INN: norursodeoxycholic acid Other descriptive name: NorUDCA | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | Hungary;Finland;Belgium;Spain;Lithuania;Denmark;Austria;Norway;Netherlands;Germany;United Kingdom;Sweden | ||
| 10 | NCT01755507 (ClinicalTrials.gov) | December 2012 | 19/12/2012 | Norursodeoxycholic Acid in the Treatment of Primary Sclerosing Cholangitis | Double-blind,Randomized, Placebo-controlled, Phase II Dose-finding Study Comparing Different Doses of Norursodeoxycholic Acid Capsules With Placebo in the Treatment of Primary Sclerosing Cholangitis | Primary Sclerosing Cholangitis | Drug: norUDCA;Drug: Placebo | Dr. Falk Pharma GmbH | NULL | Completed | 18 Years | 80 Years | Both | 159 | Phase 2 | Austria;Germany;Norway |
| 11 | EUCTR2011-002754-31-NO (EUCTR) | 13/11/2012 | 28/06/2012 | Double-blind (neither physician nor patient knows of the actual treatment which can be with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (tested against capsules without active substance), phase II dose-finding study comparing different doses of norursodeoxycholic acid capsules with placebo (without active substance) in the treatment of PSC (inflammation of the bile ducts with scar formation) | Double-blind, randomized, placebo-controlled, phase II dose-finding study comparing different doses of norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis - Norursodeoxycholic acid vs. Placebo in PSC | primary sclerosing cholangitis MedDRA version: 14.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: norursodeoxycholic acid INN or Proposed INN: norursodeoxycholic acid Other descriptive name: NorUDCA | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 160 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Hungary;Finland;Belgium;Spain;Lithuania;Denmark;Austria;Netherlands;Germany;Norway;United Kingdom;Sweden | ||
| 12 | EUCTR2011-002754-31-ES (EUCTR) | 12/11/2012 | 19/07/2012 | Double-blind (neither physician nor patient knows of the actual treatment which can be with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (tested against capsules without active substance), phase II dose-finding study comparing different doses of norursodeoxycholic acid capsules with placebo (without active substance) in the treatment of PSC (inflammation of the bile ducts with scar formation) | Double-blind, randomized, placebo-controlled, phase II dose-finding study comparing different doses of norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis - Norursodeoxycholic acid vs. Placebo in PSC | primary sclerosing cholangitis MedDRA version: 14.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: norursodeoxycholic acid INN or Proposed INN: norursodeoxycholic acid Other descriptive name: NorUDCA | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | Hungary;Finland;Belgium;Spain;Lithuania;Denmark;Austria;Norway;Netherlands;Germany;United Kingdom;Sweden | ||
| 13 | EUCTR2011-002754-31-FI (EUCTR) | 19/10/2012 | 02/08/2012 | Double-blind (neither physician nor patient knows of the actual treatment which can be with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (tested against capsules without active substance), phase II dose-finding study comparing different doses of norursodeoxycholic acid capsules with placebo (without active substance) in the treatment of PSC (inflammation of the bile ducts with scar formation) | Double-blind, randomized, placebo-controlled, phase II dose-finding study comparing different doses of norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis - Norursodeoxycholic acid vs. Placebo in PSC | primary sclerosing cholangitis MedDRA version: 17.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: norursodeoxycholic acid INN or Proposed INN: norursodeoxycholic acid Other descriptive name: NorUDCA | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | Hungary;Finland;Belgium;Spain;Lithuania;Denmark;Austria;Norway;Netherlands;Germany;United Kingdom;Sweden | ||
| 14 | EUCTR2011-002754-31-NL (EUCTR) | 01/10/2012 | 13/06/2012 | Double-blind (neither physician nor patient knows of the actual treatment which can be with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (tested against capsules without active substance), phase II dose-finding study comparing different doses of norursodeoxycholic acid capsules with placebo (without active substance) in the treatment of PSC (inflammation of the bile ducts with scar formation) | Double-blind, randomized, placebo-controlled, phase II dose-finding study comparing different doses of norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis - Norursodeoxycholic acid vs. Placebo in PSC | primary sclerosing cholangitis MedDRA version: 17.0;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: norursodeoxycholic acid INN or Proposed INN: norursodeoxycholic acid Other descriptive name: NorUDCA | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | Hungary;Finland;Belgium;Spain;Lithuania;Denmark;Austria;Norway;Germany;Netherlands;United Kingdom;Sweden | ||
| 15 | EUCTR2011-002754-31-DK (EUCTR) | 21/09/2012 | 17/08/2012 | Double-blind (neither physician nor patient knows of the actual treatment which can be with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (tested against capsules without active substance), phase II dose-finding study comparing different doses of norursodeoxycholic acid capsules with placebo (without active substance) in the treatment of PSC (inflammation of the bile ducts with scar formation) | Double-blind, randomized, placebo-controlled, phase II dose-finding study comparing different doses of norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis - Norursodeoxycholic acid vs. Placebo in PSC | primary sclerosing cholangitis MedDRA version: 18.0;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: norursodeoxycholic acid INN or Proposed INN: norursodeoxycholic acid Other descriptive name: NorUDCA | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | Hungary;Finland;Belgium;Spain;Lithuania;Austria;Denmark;Norway;Netherlands;Germany;United Kingdom;Sweden | ||
| 16 | EUCTR2011-002754-31-LT (EUCTR) | 12/09/2012 | 21/06/2012 | Double-blind (neither physician nor patient knows of the actual treatment which can be with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (tested against capsules without active substance), phase II dose-finding study comparing different doses of norursodeoxycholic acid capsules with placebo (without active substance) in the treatment of PSC (inflammation of the bile ducts with scar formation) | Double-blind, randomized, placebo-controlled, phase II dose-finding study comparing different doses of norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis - Norursodeoxycholic acid vs. Placebo in PSC | primary sclerosing cholangitis MedDRA version: 16.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: norursodeoxycholic acid INN or Proposed INN: norursodeoxycholic acid Other descriptive name: NorUDCA | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | Hungary;Finland;Belgium;Spain;Lithuania;Denmark;Austria;Norway;Netherlands;Germany;United Kingdom;Sweden | ||
| 17 | EUCTR2011-002754-31-SE (EUCTR) | 11/09/2012 | 09/07/2012 | Double-blind (neither physician nor patient knows of the actual treatment which can be with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (tested against capsules without active substance), phase II dose-finding study comparing different doses of norursodeoxycholic acid capsules with placebo (without active substance) in the treatment of PSC (inflammation of the bile ducts with scar formation) | Double-blind, randomized, placebo-controlled, phase II dose-finding study comparing different doses of norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis - Norursodeoxycholic acid vs. Placebo in PSC | primary sclerosing cholangitis MedDRA version: 18.0;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: norursodeoxycholic acid INN or Proposed INN: norursodeoxycholic acid Other descriptive name: NorUDCA | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | Hungary;Finland;Belgium;Spain;Lithuania;Denmark;Austria;Norway;Netherlands;Germany;United Kingdom;Sweden | ||
| 18 | EUCTR2011-002754-31-HU (EUCTR) | 09/08/2012 | 14/08/2012 | Double-blind (neither physician nor patient knows of the actual treatment which can be with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (tested against capsules without active substance), phase II dose-finding study comparing different doses of norursodeoxycholic acid capsules with placebo (without active substance) in the treatment of PSC (inflammation of the bile ducts with scar formation) | Double-blind, randomized, placebo-controlled, phase II dose-finding study comparing different doses of norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis - Norursodeoxycholic acid vs. Placebo in PSC | primary sclerosing cholangitis MedDRA version: 16.0;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: norursodeoxycholic acid INN or Proposed INN: norursodeoxycholic acid Other descriptive name: NorUDCA | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | Hungary;Finland;Belgium;Spain;Lithuania;Denmark;Austria;Norway;Netherlands;Germany;United Kingdom;Sweden | ||
| 19 | EUCTR2011-002754-31-DE (EUCTR) | 02/08/2012 | 11/05/2012 | Double-blind (neither physician nor patient knows of the actual treatment which can be with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (tested against capsules without active substance), phase II dose-finding study comparing different doses of norursodeoxycholic acid capsules with placebo (without active substance) in the treatment of PSC (inflammation of the bile ducts with scar formation) | Double-blind, randomized, placebo-controlled, phase II dose-finding study comparing different doses of norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis - Norursodeoxycholic acid vs. Placebo in PSC | primary sclerosing cholangitis MedDRA version: 18.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: norursodeoxycholic acid INN or Proposed INN: norursodeoxycholic acid Other descriptive name: NorUDCA | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | Hungary;Finland;Belgium;Spain;Lithuania;Denmark;Austria;Norway;Netherlands;Germany;United Kingdom;Sweden | ||
| 20 | EUCTR2011-002754-31-AT (EUCTR) | 12/07/2012 | 05/06/2012 | Double-blind (neither physician nor patient knows of the actual treatment which can be with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (tested against capsules without active substance), phase II dose-finding study comparing different doses of norursodeoxycholic acid capsules with placebo (without active substance) in the treatment of PSC (inflammation of the bile ducts with scar formation) | Double-blind, randomized, placebo-controlled, phase II dose-finding study comparing different doses of norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis - Norursodeoxycholic acid vs. Placebo in PSC | primary sclerosing cholangitis MedDRA version: 16.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: norursodeoxycholic acid INN or Proposed INN: norursodeoxycholic acid Other descriptive name: NorUDCA | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | Hungary;Finland;Belgium;Spain;Lithuania;Denmark;Austria;Norway;Netherlands;Germany;United Kingdom;Sweden | ||
| 21 | EUCTR2016-003367-19-IE (EUCTR) | 12/11/2018 | A study to compare norursodeoxycholic acid with placebo in the treatment of primary sclerosing cholangitis | Double-blind, randomized, placebo-controlled, phase III study comparing norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis | Primary Sclerosing Cholangitis (PSC) is a slowly progressing chronic cholestatic liver disease of assumed autoimmune, but finally unidentified etiology, characterized by a chronic inflammatory and fibro-obliterative destruction of extra-, and intrahepatic bile ducts. The disease is characterized by diffuse inflammation, fibrosis, and strictures of the intra- and/or extrahepatic bile ducts with an impaired biliary secretion of potentially aggressive bile fluid often leading to cirrhosis. MedDRA version: 20.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Norursodeoxycholic acid INN or Proposed INN: Norursodeoxycholic acid Other descriptive name: NorUDCA | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Sweden;Netherlands;Germany;Denmark;Belgium;Poland;Czech Republic;Hungary;France;United Kingdom;Switzerland;Austria;Lithuania;Ireland;Finland |