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Colesevelam Versus Placebo in Cholestatic Pruritus

NCT ID: NCT00756171

Last Updated: 2012-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-12-31

Brief Summary

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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

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Conditions

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Chronic Liver Disease

Keywords

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Cholestatic pruritus of any cause

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Verum; colesevelam

Group Type EXPERIMENTAL

colesevelam

Intervention Type DRUG

2 times 3 625 mg tablets daily, 3 weeks

2

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

2 times 3 625mg tablets daily

Interventions

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colesevelam

2 times 3 625 mg tablets daily, 3 weeks

Intervention Type DRUG

placebo

2 times 3 625mg tablets daily

Intervention Type DRUG

Other Intervention Names

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Cholestagel

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Foundation for Liver Research

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Amsterdam Medical Center

Amsterdam, , Netherlands

Site Status

Erasmus Medical Center

Rotterdam, , Netherlands

Site Status

University Medical Center Utrecht

Utrecht, , Netherlands

Site Status

Countries

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Netherlands

References

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Kuiper EM, van Erpecum KJ, Beuers U, Hansen BE, Thio HB, de Man RA, Janssen HL, van Buuren HR. The potent bile acid sequestrant colesevelam is not effective in cholestatic pruritus: results of a double-blind, randomized, placebo-controlled trial. Hepatology. 2010 Oct;52(4):1334-40. doi: 10.1002/hep.23821.

Reference Type DERIVED
PMID: 20683930 (View on PubMed)

Other Identifiers

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COPE_08

Identifier Type: -

Identifier Source: org_study_id