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Colesevelam Versus Placebo in Cholestatic Pruritus — COPE  

Chronic Liver Disease Clinical Trial

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

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.

Clinical Trial Description

n/a

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

Clinical Trial Details
NCT number NCT00756171
Study type Interventional
Source Foundation for Liver Research
Contact
Status Completed
Phase Phase 2/Phase 3
Start date September 2008
Completion date December 2009
View Details
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