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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00756171
Other study ID # COPE_08
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received September 18, 2008
Last updated December 17, 2012
Start date September 2008
Est. completion date December 2009

Study information

Verified date December 2012
Source Foundation for Liver Research
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date December 2009
Est. primary completion date May 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
colesevelam
2 times 3 625 mg tablets daily, 3 weeks
placebo
2 times 3 625mg tablets daily

Locations

Country Name City State
Netherlands Amsterdam Medical Center Amsterdam
Netherlands Erasmus Medical Center Rotterdam
Netherlands University Medical Center Utrecht Utrecht

Sponsors (1)

Lead Sponsor Collaborator
Foundation for Liver Research

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 40% reduction of pruritus according to visual analogue scores 3 weeks No
Secondary improvement in quality of life scores 3 weeks No
Secondary Reduction in pruritus score/scratch lesions 3 weeks No
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