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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
38
2 times 3 625 mg tablets daily, 3 weeks
2 times 3 625mg tablets daily
Amsterdam Medical Center
Amsterdam, Netherlands
Erasmus Medical Center
Rotterdam, Netherlands
University Medical Center Utrecht
Utrecht, Netherlands
40% reduction of pruritus according to visual analogue scores
Time frame: 3 weeks
improvement in quality of life scores
Time frame: 3 weeks
Reduction in pruritus score/scratch lesions
Time frame: 3 weeks
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