Colesevelam Versus Placebo in Cholestatic Pruritus

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Foundation for Liver Research
• Treatments: Colesevelam Hydrochloride

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