Colesevelam Versus Placebo in Cholestatic Pruritus (COPE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Foundation for Liver Research
ClinicalTrials.gov Identifier:
NCT00756171
First received: September 18, 2008
Last updated: December 17, 2012
Last verified: December 2012
  Purpose

38 patients with pruritus due to chronic cholestatic liver disease will be evaluated in an investigator initiated, multicenter, double-blind, placebo-controlled, 3-week study assessing the effects of colesevelam on pruritus. Colesevelam is an oral, non-absorbable bile-acid sequestrant much more potent than cholestyramine but free of adverse effects. It is registered as a lipid lowering agent. The intensity of symptoms will be scored by means of daily Visual Analogue Scales (VAS). Fatigue, quality of life and cutaneous scratch lesions will also be evaluated using quantitative instruments.


Condition Intervention Phase
Chronic Liver Disease
Drug: colesevelam
Drug: placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Colesevelam Versus Placebo in Cholestatic Pruritus. A Double-blind, Placebo-controlled Study

Resource links provided by NLM:


Further study details as provided by Foundation for Liver Research:

Primary Outcome Measures:
  • 40% reduction of pruritus according to visual analogue scores [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • improvement in quality of life scores [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Reduction in pruritus score/scratch lesions [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: September 2008
Study Completion Date: December 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Verum; colesevelam
Drug: colesevelam
2 times 3 625 mg tablets daily, 3 weeks
Other Name: Cholestagel
Placebo Comparator: 2
placebo
Drug: placebo
2 times 3 625mg tablets daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with pruritus as a result of a cholestatic disorder
  • age above 18 years
  • informed consent

Exclusion Criteria:

  • use of cholestyramine
  • pregnancy
  • inability to understand or speak Dutch language
  • malignancy/life expectancy <6 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00756171

Locations
Netherlands
Amsterdam Medical Center
Amsterdam, Netherlands
Erasmus Medical Center
Rotterdam, Netherlands
University Medical Center Utrecht
Utrecht, Netherlands
Sponsors and Collaborators
Foundation for Liver Research
  More Information

No publications provided by Foundation for Liver Research

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Foundation for Liver Research
ClinicalTrials.gov Identifier: NCT00756171     History of Changes
Other Study ID Numbers: COPE_08
Study First Received: September 18, 2008
Last Updated: December 17, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Foundation for Liver Research:
Cholestatic
pruritus
of any cause

Additional relevant MeSH terms:
Liver Diseases
Pruritus
Digestive System Diseases
Skin Diseases
Skin Manifestations
Signs and Symptoms
Colesevelam
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014