Colesevelam Versus Placebo in Cholestatic Pruritus (COPE)

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Foundation for Liver Research

ClinicalTrials.gov Identifier:

NCT00756171

First received: September 18, 2008

Last updated: September 6, 2011

Last verified: September 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	September 18, 2008
Last Updated Date	September 6, 2011
Start Date ^ICMJE	September 2008
Estimated Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 18, 2008)	40% reduction of pruritus according to visual analogue scores [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00756171 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 18, 2008)	improvement in quality of life scores [ Time Frame: 3 weeks ] [ Designated as safety issue: No ] Reduction in pruritus score/scratch lesions [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Colesevelam Versus Placebo in Cholestatic Pruritus
Official Title ^ICMJE	Colesevelam Versus Placebo in Cholestatic Pruritus. A Double-blind, Placebo-controlled Study
Brief 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.
Detailed Description
Study Type ^ICMJE	Interventional
Study Phase	Phase 2 Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Chronic Liver Disease
Intervention ^ICMJE	Drug: colesevelam 2 times 3 625 mg tablets daily, 3 weeks Other Name: Cholestagel Drug: placebo 2 times 3 625mg tablets daily
Study Arm (s)	Experimental: 1 Verum; colesevelam Intervention: Drug: colesevelam Placebo Comparator: 2 placebo Intervention: Drug: placebo
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	38
Estimated Completion Date	May 2012
Estimated Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Netherlands

Administrative Information
NCT Number ^ICMJE	NCT00756171
Other Study ID Numbers ^ICMJE	COPE_08
Has Data Monitoring Committee	Yes
Responsible Party	Foundation for Liver Research
Study Sponsor ^ICMJE	Foundation for Liver Research
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Foundation for Liver Research
Verification Date	September 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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