93. Primary biliary cholangitis Clinical trials / Disease details


Clinical trials : 298 Drugs : 252 - (DrugBank : 59) / Drug target genes : 35 - Drug target pathways : 115

  
2 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2008-001524-31-NL
(EUCTR)
26/11/200817/07/2008Double-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 PBCDouble-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 GmbHNULLNot RecruitingFemale: yes
Male: yes
74Phase 4Germany;Netherlands
2EUCTR2008-001524-31-DE
(EUCTR)
26/08/200811/07/2008Double-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 PBCDouble-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 GmbHNULLNot RecruitingFemale: yes
Male: yes
74Phase 4Germany;Netherlands