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Colesevelam Versus Placebo in Cholestatic Pruritus (COPE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00756171
First Posted: September 19, 2008
Last Update Posted: December 18, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Foundation for Liver Research
  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 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Colesevelam Versus Placebo in Cholestatic Pruritus. A Double-blind, Placebo-controlled Study

Resource links provided by NLM:


Further study details as provided by Foundation for Liver Research:

Primary Outcome Measures:
  • 40% reduction of pruritus according to visual analogue scores [ Time Frame: 3 weeks ]

Secondary Outcome Measures:
  • improvement in quality of life scores [ Time Frame: 3 weeks ]
  • Reduction in pruritus score/scratch lesions [ Time Frame: 3 weeks ]

Enrollment: 38
Study Start Date: September 2008
Study Completion Date: December 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Verum; colesevelam
Drug: colesevelam
2 times 3 625 mg tablets daily, 3 weeks
Other Name: Cholestagel
Placebo Comparator: 2
placebo
Drug: placebo
2 times 3 625mg tablets daily

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00756171


Locations
Netherlands
Amsterdam Medical Center
Amsterdam, Netherlands
Erasmus Medical Center
Rotterdam, Netherlands
University Medical Center Utrecht
Utrecht, Netherlands
Sponsors and Collaborators
Foundation for Liver Research
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Foundation for Liver Research
ClinicalTrials.gov Identifier: NCT00756171     History of Changes
Other Study ID Numbers: COPE_08
First Submitted: September 18, 2008
First Posted: September 19, 2008
Last Update Posted: December 18, 2012
Last Verified: December 2012

Keywords provided by Foundation for Liver Research:
Cholestatic
pruritus
of any cause

Additional relevant MeSH terms:
Liver Diseases
Pruritus
Digestive System Diseases
Skin Diseases
Skin Manifestations
Signs and Symptoms
Colesevelam Hydrochloride
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents