NCT01755507

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 159 (actual)
• Sponsor: Dr. Falk Pharma GmbH · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Evaluation of the efficacy of different doses of nor UDCA vs. placebo for the treatment of Primary Sclerosing Cholangitis (PSC). Identification of optimal dose(s)for the treatment of PSC.

Detailed description

Double-blind, randomized, multi-center, placebo-controlled, comparative exploratory phase II-finding trial.The study will be conducted with four treatment groups in the form of a parallel-group comparison and will serve to compare oral treatment with either 500 mg/d, 1000 mg/d or 1500 mg/d norursodeoxycholic acid capsules vs. Placebo capsules for the treatment of PSC.

Conditions

• Primary Sclerosing Cholangitis

Interventions

Type	Name	Description
DRUG	norUDCA	Comparison of different dosages of norUDCA acid administered orally.
DRUG	Placebo

Timeline

• Start date: 2012-12-01
• Primary completion: 2015-10-01
• Completion: 2015-12-01
• First posted: 2012-12-24
• Last updated: 2016-08-03

Locations

3 sites across 3 countries: Austria, Germany, Norway