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Colesevelam Versus Placebo in Cholestatic Pruritus (COPE)

Primary Purpose

Chronic Liver Disease

Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
colesevelam
placebo
Sponsored by
Foundation for Liver Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Liver Disease focused on measuring Cholestatic, pruritus, of any cause

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Amsterdam Medical Center
  • Erasmus Medical Center
  • University Medical Center Utrecht

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Verum; colesevelam

placebo

Outcomes

Primary Outcome Measures

40% reduction of pruritus according to visual analogue scores

Secondary Outcome Measures

improvement in quality of life scores
Reduction in pruritus score/scratch lesions

Full Information

First Posted
September 18, 2008
Last Updated
December 17, 2012
Sponsor
Foundation for Liver Research
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1. Study Identification

Unique Protocol Identification Number
NCT00756171
Brief Title
Colesevelam Versus Placebo in Cholestatic Pruritus
Acronym
COPE
Official Title
Colesevelam Versus Placebo in Cholestatic Pruritus. A Double-blind, Placebo-controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Foundation for Liver Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Liver Disease
Keywords
Cholestatic, pruritus, of any cause

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Verum; colesevelam
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
colesevelam
Other Intervention Name(s)
Cholestagel
Intervention Description
2 times 3 625 mg tablets daily, 3 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
2 times 3 625mg tablets daily
Primary Outcome Measure Information:
Title
40% reduction of pruritus according to visual analogue scores
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
improvement in quality of life scores
Time Frame
3 weeks
Title
Reduction in pruritus score/scratch lesions
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Amsterdam Medical Center
City
Amsterdam
Country
Netherlands
Facility Name
Erasmus Medical Center
City
Rotterdam
Country
Netherlands
Facility Name
University Medical Center Utrecht
City
Utrecht
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
20683930
Citation
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.
Results Reference
derived

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Colesevelam Versus Placebo in Cholestatic Pruritus

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