NCT00756171

Colesevelam Versus Placebo in Cholestatic Pruritus

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Foundation for Liver Research · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Liver Disease

Interventions

Type	Name	Description
DRUG	colesevelam	2 times 3 625 mg tablets daily, 3 weeks
DRUG	placebo	2 times 3 625mg tablets daily

Timeline

• Start date: 2008-09-01
• Primary completion: 2009-05-01
• Completion: 2009-12-01
• First posted: 2008-09-19
• Last updated: 2012-12-18

Locations

3 sites across 1 country: Netherlands