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Colesevelam Versus Placebo in Cholestatic Pruritus (COPE)

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ClinicalTrials.gov Identifier: NCT00756171
Recruitment Status : Completed
First Posted : September 19, 2008
Last Update Posted : December 18, 2012
Sponsor:
Information provided by (Responsible Party):
Foundation for Liver Research

Tracking Information
First Submitted Date  ICMJE September 18, 2008
First Posted Date  ICMJE September 19, 2008
Last Update Posted Date December 18, 2012
Study Start Date  ICMJE September 2008
Actual Primary Completion Date May 2009   (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 ]
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 ]
  • Reduction in pruritus score/scratch lesions [ Time Frame: 3 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Arms  ICMJE
  • 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. doi: 10.1002/hep.23821.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: September 18, 2008)
38
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date May 2009   (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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00756171
Other Study ID Numbers  ICMJE COPE_08
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Foundation for Liver Research
Study Sponsor  ICMJE Foundation for Liver Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Foundation for Liver Research
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP