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OpenTrials
Completed

NCT Number: NCT00756171

Colesevelam Versus Placebo in Cholestatic Pruritus

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.

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Key information

Conditions

Chronic Liver Disease Pathological Conditions, Signs and Symptoms Pruritus Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Amsterdam Medical Center, Amsterdam, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Colesevelam

Drug

2 times 3 625 mg tablets daily, 3 weeks

Other names: Cholestagel

Placebo

Drug

2 times 3 625mg tablets daily

Primary outcomes

  1. 40% reduction of pruritus according to visual analogue scores

    Time frame: 3 weeks

Secondary outcomes

  1. improvement in quality of life scores

    Time frame: 3 weeks

  2. Reduction in pruritus score/scratch lesions

    Time frame: 3 weeks

Sponsors and collaborators

Lead sponsor

Foundation for Liver Research

Other

Registry information

Official study title

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

Acronym: COPE

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Sep 19, 2008
Registry last updated
Dec 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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