Colesevelam Versus Placebo in Cholestatic Pruritus
- Registration Number
- NCT00756171
- Lead Sponsor
- Foundation for Liver Research
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
- patients with pruritus as a result of a cholestatic disorder
- age above 18 years
- informed consent
- use of cholestyramine
- pregnancy
- inability to understand or speak Dutch language
- malignancy/life expectancy <6 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 placebo placebo 1 colesevelam Verum; colesevelam
- Primary Outcome Measures
Name Time Method 40% reduction of pruritus according to visual analogue scores 3 weeks
- Secondary Outcome Measures
Name Time Method improvement in quality of life scores 3 weeks Reduction in pruritus score/scratch lesions 3 weeks
Trial Locations
- Locations (3)
Erasmus Medical Center
🇳🇱Rotterdam, Netherlands
Amsterdam Medical Center
🇳🇱Amsterdam, Netherlands
University Medical Center Utrecht
🇳🇱Utrecht, Netherlands