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Norursodeoxycholic Acid in the Treatment of Primary Sclerosing Cholangitis (NUC-3)

This study has been completed.
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH Identifier:
First received: December 19, 2012
Last updated: August 2, 2016
Last verified: August 2016
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.

Condition Intervention Phase
Primary Sclerosing Cholangitis
Drug: norUDCA
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Sclerosing Cholangitis

Resource links provided by NLM:

Further study details as provided by Dr. Falk Pharma GmbH:

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

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

Other Outcome Measures:
  • Adverse Events [ Time Frame: 12 weeks ]

Enrollment: 159
Study Start Date: December 2012
Study Completion Date: December 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: B
Drug: norUDCA
Comparison of different dosages of norUDCA acid administered orally.
Experimental: C
Drug: norUDCA
Comparison of different dosages of norUDCA acid administered orally.
Placebo Comparator: placebo
Drug: Placebo
Experimental: A
Drug: norUDCA
Comparison of different dosages of norUDCA acid administered orally.

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.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Signed Informed Consent
  2. Verified diagnosis of PSC
  3. PSC patients with or without IBD
  4. Women of childbearing potential have to apply during the entire duration of the study a highly effective method of birth control.

Exclusion Criteria:

  1. History or presence of other concomitant liver diseases
  2. Treatment with UDCA within 8 weeks prior to baseline visit.
  3. Child B/C liver cirrhosis
  4. Total bilirubin > 3.0 mg/dl at screening or baseline.
  5. Any relevant systemic disease
  6. TSH>ULN at screening
  7. any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder
  8. Any active malignant disease
  9. Known intolerance/hypersensitivity to study drug
  10. Existing or intended pregnancy of brest feeding
  11. Simultaneous participation in another clinical trial
  Contacts and Locations
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Please refer to this study by its identifier: NCT01755507

Prof. M. Trauner
Wien, Austria, 1090
Prof. Michael Manns
Hannover, Germany, 30623
Kirsten Boberg
Oslo, Norway, 0424
Sponsors and Collaborators
Dr. Falk Pharma GmbH
Principal Investigator: Michael Trauner, Prof Med. Uni Wien
Principal Investigator: Michael P Manns, Prof Med. Hochschule Hannover
  More Information

Responsible Party: Dr. Falk Pharma GmbH Identifier: NCT01755507     History of Changes
Other Study ID Numbers: NUC-3/PSC
Study First Received: December 19, 2012
Last Updated: August 2, 2016

Keywords provided by Dr. Falk Pharma GmbH:

Additional relevant MeSH terms:
Cholangitis, Sclerosing
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases processed this record on May 24, 2017