Colesevelam Versus Placebo in Cholestatic Pruritus

Chronic Liver Disease Clinical Trial

— COPE  

Official title:

Colesevelam Versus Placebo in Cholestatic Pruritus. A Double-blind, Placebo-controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00756171
• Other study ID #: COPE_08
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 18, 2008
• Last updated: December 17, 2012
• Start date: September 2008
• Est. completion date: December 2009

Study information

• Verified date: December 2012
• Source: Foundation for Liver Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Liver Disease
• Liver Diseases
• Pruritus

Intervention

Drug:
• colesevelam
2 times 3 625 mg tablets daily, 3 weeks
• placebo
2 times 3 625mg tablets daily

Locations

Country	Name	City	State
Netherlands	Amsterdam Medical Center	Amsterdam
Netherlands	Erasmus Medical Center	Rotterdam
Netherlands	University Medical Center Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
Foundation for Liver Research

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	40% reduction of pruritus according to visual analogue scores		3 weeks	No
Secondary	improvement in quality of life scores		3 weeks	No
Secondary	Reduction in pruritus score/scratch lesions		3 weeks	No