94. 原発性硬化性胆管炎 Primary sclerosing cholangitis Clinical trials / Disease details


臨床試験数 : 148 薬物数 : 118 - (DrugBank : 39) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 141

  
30 trials found
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1EUCTR2016-003367-19-NL
(EUCTR)
22/01/201906/02/2018A study to compare norursodeoxycholic acid with placebo in the treatment of primary sclerosing cholangitisDouble-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 GmbHNULLAuthorised-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): noFinland;Ireland;Lithuania;Austria;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Netherlands;Germany;Sweden
2EUCTR2016-003367-19-PL
(EUCTR)
20/11/201828/05/2018A study to compare norursodeoxycholic acid with placebo in the treatment of primary sclerosing cholangitisDouble-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 GmbHNULLNot RecruitingFemale: yes
Male: yes
300Phase 3Czechia;Finland;Spain;Ireland;Lithuania;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Norway;Germany;Netherlands;Sweden
3EUCTR2016-003367-19-IT
(EUCTR)
22/10/201805/01/2021A study to compare norursodeoxycholic acid with placebo in the treatment of primary sclerosing cholangitisDouble-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 GMBHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3Finland;Ireland;Lithuania;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Norway;Germany;Netherlands;Sweden
4EUCTR2016-003367-19-SE
(EUCTR)
25/04/201812/02/2018A study to compare norursodeoxycholic acid with placebo in the treatment of primary sclerosing cholangitisDouble-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: Norucholic acid
Other descriptive name: Norursodeoxycholic acid, NCA
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3Czechia;Finland;Spain;Ireland;Lithuania;Austria;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Sweden
5EUCTR2016-003367-19-CZ
(EUCTR)
09/04/201808/01/2018A study to compare norursodeoxycholic acid with placebo in the treatment of primary sclerosing cholangitisDouble-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: Norucholic acid
Other descriptive name: Norursodeoxycholic acid, NCA
Dr. Falk Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
300Phase 3Czechia;Finland;Spain;Ireland;Lithuania;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Belgium;Poland;Denmark;Germany;Netherlands;Norway;Sweden
6EUCTR2016-003367-19-FR
(EUCTR)
06/04/201808/02/2018A study to compare norursodeoxycholic acid with placebo in the treatment of primary sclerosing cholangitisDouble-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 GmbHNULLAuthorised-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): noFinland;Ireland;Lithuania;Austria;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands;Sweden
7EUCTR2016-003367-19-BE
(EUCTR)
30/03/201809/01/2018A study to compare norursodeoxycholic acid with placebo in the treatment of primary sclerosing cholangitisDouble-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: Norucholic acid
Other descriptive name: Norursodeoxycholic acid, NCA
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3Czechia;Finland;Spain;Ireland;Lithuania;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Belgium;Poland;Denmark;Germany;Netherlands;Norway;Sweden
8EUCTR2016-003367-19-DK
(EUCTR)
20/03/201801/02/2018A study to compare norursodeoxycholic acid with placebo in the treatment of primary sclerosing cholangitisDouble-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: Norucholic acid
Other descriptive name: Norursodeoxycholic acid, NCA
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3Czechia;Finland;Spain;Ireland;Lithuania;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Belgium;Poland;Denmark;Germany;Netherlands;Norway;Sweden
9EUCTR2016-003367-19-GB
(EUCTR)
12/02/201821/07/2017A study to compare norursodeoxycholic acid with placebo in the treatment of primary sclerosing cholangitisDouble-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 GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3Czechia;Finland;Spain;Ireland;Lithuania;Austria;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Germany;Netherlands;Norway;Sweden
10NCT03872921
(ClinicalTrials.gov)
February 8, 20188/3/2019norUrsodeoxycholic Acid vs Placebo in PSCDouble-blind, Randomized, Placebo-controlled, Phase III Study Comparing norUrsodeoxycholic Acid Capsules With Placebo in the Treatment of Primary Sclerosing CholangitisPrimary Sclerosing CholangitisDrug: norUrsodeoxycholic AcidDr. Falk Pharma GmbHNULLRecruiting16 Years75 YearsAll300Phase 3Austria;Germany
11EUCTR2016-003367-19-FI
(EUCTR)
09/01/201811/12/2017A study to compare norursodeoxycholic acid with placebo in the treatment of primary sclerosing cholangitisDouble-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: Norucholic acid
Other descriptive name: Norursodeoxycholic acid, NCA
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3Czechia;Finland;Spain;Ireland;Lithuania;Austria;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Denmark;Netherlands;Germany;Norway;Sweden
12EUCTR2016-003367-19-LT
(EUCTR)
29/12/201704/12/2017A study to compare norursodeoxycholic acid with placebo in the treatment of primary sclerosing cholangitisDouble-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 GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3Czechia;Finland;Spain;Ireland;Lithuania;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Belgium;Poland;Denmark;Germany;Netherlands;Norway;Sweden
13EUCTR2016-003367-19-HU
(EUCTR)
05/10/201722/08/2017A study to compare norursodeoxycholic acid with placebo in the treatment of primary sclerosing cholangitisDouble-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 GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3Finland;Spain;Ireland;Lithuania;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands;Norway;Sweden
14EUCTR2016-003367-19-DE
(EUCTR)
28/09/201719/06/2017A study to compare norursodeoxycholic acid with placebo in the treatment of primary sclerosing cholangitisDouble-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: Norucholic acid
Other descriptive name: Norursodeoxycholic acid, NCA
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3Czechia;Finland;Spain;Ireland;Lithuania;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Belgium;Poland;Denmark;Germany;Netherlands;Norway;Sweden
15EUCTR2016-003367-19-AT
(EUCTR)
01/08/201727/06/2017A study to compare norursodeoxycholic acid with placebo in the treatment of primary sclerosing cholangitisDouble-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: Norucholic acid
Other descriptive name: Norursodeoxycholic acid, NCA
Dr. Falk Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3Czechia;Finland;Spain;Ireland;Lithuania;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Norway;Netherlands;Germany;Sweden
16EUCTR2011-002754-31-BE
(EUCTR)
13/11/201404/07/2014Double-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 GmbHNULLNot RecruitingFemale: yes
Male: yes
160Phase 2Hungary;Finland;Spain;Belgium;Lithuania;Denmark;Austria;Norway;Netherlands;Germany;United Kingdom;Sweden
17EUCTR2011-002754-31-GB
(EUCTR)
27/03/201316/07/2012Double-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 GmbHNULLNot RecruitingFemale: yes
Male: yes
160Phase 2Hungary;Finland;Belgium;Spain;Lithuania;Denmark;Austria;Norway;Netherlands;Germany;United Kingdom;Sweden
18NCT01755507
(ClinicalTrials.gov)
December 201219/12/2012Norursodeoxycholic Acid in the Treatment of Primary Sclerosing CholangitisDouble-blind,Randomized, Placebo-controlled, Phase II Dose-finding Study Comparing Different Doses of Norursodeoxycholic Acid Capsules With Placebo in the Treatment of Primary Sclerosing CholangitisPrimary Sclerosing CholangitisDrug: norUDCA;Drug: PlaceboDr. Falk Pharma GmbHNULLCompleted18 Years80 YearsBoth159Phase 2Austria;Germany;Norway
19EUCTR2011-002754-31-NO
(EUCTR)
13/11/201228/06/2012Double-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 GmbHNULLNot 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): noHungary;Finland;Belgium;Spain;Lithuania;Denmark;Austria;Netherlands;Germany;Norway;United Kingdom;Sweden
20EUCTR2011-002754-31-ES
(EUCTR)
12/11/201219/07/2012Double-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 GmbHNULLNot RecruitingFemale: yes
Male: yes
160Phase 2Hungary;Finland;Belgium;Spain;Lithuania;Denmark;Austria;Norway;Netherlands;Germany;United Kingdom;Sweden
21EUCTR2011-002754-31-FI
(EUCTR)
19/10/201202/08/2012Double-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 GmbHNULLNot RecruitingFemale: yes
Male: yes
160Phase 2Hungary;Finland;Belgium;Spain;Lithuania;Denmark;Austria;Norway;Netherlands;Germany;United Kingdom;Sweden
22EUCTR2011-002754-31-NL
(EUCTR)
01/10/201213/06/2012Double-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 GmbHNULLNot RecruitingFemale: yes
Male: yes
160Phase 2Hungary;Finland;Belgium;Spain;Lithuania;Denmark;Austria;Norway;Germany;Netherlands;United Kingdom;Sweden
23EUCTR2011-002754-31-DK
(EUCTR)
21/09/201217/08/2012Double-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 GmbHNULLNot RecruitingFemale: yes
Male: yes
160Phase 2Hungary;Finland;Belgium;Spain;Lithuania;Austria;Denmark;Norway;Netherlands;Germany;United Kingdom;Sweden
24EUCTR2011-002754-31-LT
(EUCTR)
12/09/201221/06/2012Double-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 GmbHNULLNot RecruitingFemale: yes
Male: yes
160Phase 2Hungary;Finland;Belgium;Spain;Lithuania;Denmark;Austria;Norway;Netherlands;Germany;United Kingdom;Sweden
25EUCTR2011-002754-31-SE
(EUCTR)
11/09/201209/07/2012Double-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 GmbHNULLNot RecruitingFemale: yes
Male: yes
160Phase 2Hungary;Finland;Belgium;Spain;Lithuania;Denmark;Austria;Norway;Netherlands;Germany;United Kingdom;Sweden
26EUCTR2011-002754-31-HU
(EUCTR)
09/08/201214/08/2012Double-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 GmbHNULLNot RecruitingFemale: yes
Male: yes
160Phase 2Hungary;Finland;Belgium;Spain;Lithuania;Denmark;Austria;Norway;Netherlands;Germany;United Kingdom;Sweden
27EUCTR2011-002754-31-DE
(EUCTR)
02/08/201211/05/2012Double-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 GmbHNULLNot RecruitingFemale: yes
Male: yes
160Phase 2Hungary;Finland;Belgium;Spain;Lithuania;Denmark;Austria;Norway;Netherlands;Germany;United Kingdom;Sweden
28EUCTR2011-002754-31-AT
(EUCTR)
12/07/201205/06/2012Double-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 GmbHNULLNot RecruitingFemale: yes
Male: yes
160Phase 2Hungary;Finland;Belgium;Spain;Lithuania;Denmark;Austria;Norway;Netherlands;Germany;United Kingdom;Sweden
29EUCTR2016-003367-19-IE
(EUCTR)
12/11/2018A study to compare norursodeoxycholic acid with placebo in the treatment of primary sclerosing cholangitisDouble-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 GmbHNULLNot 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): noFinland;Ireland;Lithuania;Austria;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands;Sweden
30EUCTR2016-003367-19-NO
(EUCTR)
07/03/2018A study to compare norursodeoxycholic acid with placebo in the treatment of primary sclerosing cholangitisDouble-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: Norucholic acid
Other descriptive name: Norursodeoxycholic acid, NCA
Dr. Falk Pharma GmbHNULLNAFemale: yes
Male: yes
300Phase 3Czechia;Finland;Spain;Ireland;Lithuania;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Belgium;Poland;Denmark;Norway;Germany;Netherlands;Sweden