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| Sponsored by: |
Foundation for Liver Research |
|---|---|
| Information provided by: | Foundation for Liver Research |
| ClinicalTrials.gov Identifier: | NCT00756171 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Liver Disease |
Drug: colesevelam Drug: placebo |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Colesevelam Versus Placebo in Cholestatic Pruritus. A Double-Blind, Placebo-Controlled Study |
| Estimated Enrollment: | 38 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | September 2009 |
| Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Verum; colesevelam
|
Drug: colesevelam
2 times 3 625 mg tablets daily, 3 weeks
|
|
2: Placebo Comparator
placebo
|
Drug: placebo
2 times 3 625mg tablets daily
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Edith M Kuiper, MD | 010-7033040 ext 0031 | e.m.m.kuiper@erasmusmc.nl |
| Netherlands | |
| Erasmus Medical Center | Recruiting |
| Rotterdam, Netherlands | |
| Contact: Edith M Kuiper, MD 010-7033040 ext 0031 e.m.m.kuiper@erasmusmc.nl | |
| Contact: Henk R van Buuren, MD, PhD | |
| University Medical Center Utrecht | Recruiting |
| Utrecht, Netherlands | |
| Contact: Erpecum, MD, Phd k.j.vanerpecum@umcutrecht.nl | |
| Amsterdam Medical Center | Recruiting |
| Amsterdam, Netherlands | |
| Contact: Beuers, MD, PhD u.h.beuers@amc.uva.nl | |
More Information
| Responsible Party: | ErasmusMC ( Edith Kuiper, foundation for Liver Research ) |
| Study ID Numbers: | COPE_08 |
| Study First Received: | September 18, 2008 |
| Last Updated: | April 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00756171 History of Changes |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
|
Cholestatic pruritus of any cause |
|
Antimetabolites Pruritus Signs and Symptoms Liver Diseases Colesevelam |
Digestive System Diseases Skin Diseases Antilipemic Agents Anticholesteremic Agents |
|
Pruritus Antimetabolites Skin Manifestations Liver Diseases Colesevelam Skin Diseases Molecular Mechanisms of Pharmacological Action |
Antilipemic Agents Anticholesteremic Agents Pharmacologic Actions Signs and Symptoms Digestive System Diseases Therapeutic Uses |
