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

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ClinicalTrials.gov Identifier: NCT01755507
Recruitment Status : Completed
First Posted : December 24, 2012
Last Update Posted : August 3, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Falk Pharma GmbH

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.

Condition or disease Intervention/treatment Phase
Primary Sclerosing Cholangitis Drug: norUDCA Drug: Placebo Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 159 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (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
Study Start Date : December 2012
Actual Primary Completion Date : October 2015
Actual Study Completion Date : December 2015


Arm Intervention/treatment
Experimental: B
norUDCA
Drug: norUDCA
Comparison of different dosages of norUDCA acid administered orally.
Experimental: C
norUDCA
Drug: norUDCA
Comparison of different dosages of norUDCA acid administered orally.
Placebo Comparator: placebo
Placebo
Drug: Placebo
Experimental: A
norUDCA
Drug: norUDCA
Comparison of different dosages of norUDCA acid administered orally.



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

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

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


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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01755507


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Falk Pharma GmbH
ClinicalTrials.gov Identifier: NCT01755507     History of Changes
Other Study ID Numbers: NUC-3/PSC
First Posted: December 24, 2012    Key Record Dates
Last Update Posted: August 3, 2016
Last Verified: August 2016

Keywords provided by Dr. Falk Pharma GmbH:
PSC

Additional relevant MeSH terms:
Cholangitis
Cholangitis, Sclerosing
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases