Clinical Trial: Norursodeoxycholic Acid in the Treatment of Primary Sclerosing Cholangitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Double-blind,Randomized, Placebo-controlled, Phase II Dose-finding Study Comparing Different Doses of Norursodeoxycholic Acid Capsules With Placebo in the Treatment of Primary Sc

Brief 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 Summary: 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.
Sponsor: Dr. Falk Pharma GmbH

Current Primary Outcome: Change in serum AP levels during treatment [ Time Frame: 12 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Proportion of patients with at least 50% reduction in s-ALP [ Time Frame: 12 weeks ]

Original Secondary Outcome: Same as current

Information By: Dr. Falk Pharma GmbH

Dates:
Date Received: December 19, 2012
Date Started: December 2012
Date Completion:
Last Updated: August 2, 2016
Last Verified: August 2016