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Norursodeoxycholic Acid in the Treatment of Primary Sclerosing Cholangitis

NCT01755507 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2016-08-03

No results posted yet for this study

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.

Conditions

  • Primary Sclerosing Cholangitis

Interventions

DRUG

norUDCA

Comparison of different dosages of norUDCA acid administered orally.

DRUG

Placebo

Sponsors & Collaborators

  • Dr. Falk Pharma GmbH

    lead INDUSTRY

Principal Investigators

  • Michael Trauner, Prof · Med. Uni Wien

  • Michael P Manns, Prof · Med.Hochschule Hannover

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2015-10-31
Completion
2015-12-31

Countries

  • Austria
  • Germany
  • Norway

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01755507 on ClinicalTrials.gov