Colesevelam Versus Placebo in Cholestatic Pruritus
COPE
1 other identifier
interventional
38
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2008
Shorter than P25 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 18, 2008
CompletedFirst Posted
Study publicly available on registry
September 19, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedDecember 18, 2012
December 1, 2012
8 months
September 18, 2008
December 17, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
40% reduction of pruritus according to visual analogue scores
3 weeks
Secondary Outcomes (2)
improvement in quality of life scores
3 weeks
Reduction in pruritus score/scratch lesions
3 weeks
Study Arms (2)
1
EXPERIMENTALVerum; colesevelam
2
PLACEBO COMPARATORplacebo
Interventions
Eligibility Criteria
You may qualify if:
- patients with pruritus as a result of a cholestatic disorder
- age above 18 years
- informed consent
You may not qualify if:
- use of cholestyramine
- pregnancy
- inability to understand or speak Dutch language
- malignancy/life expectancy \<6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Amsterdam Medical Center
Amsterdam, Netherlands
Erasmus Medical Center
Rotterdam, Netherlands
University Medical Center Utrecht
Utrecht, Netherlands
Related Publications (1)
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.
PMID: 20683930DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2008
First Posted
September 19, 2008
Study Start
September 1, 2008
Primary Completion
May 1, 2009
Study Completion
December 1, 2009
Last Updated
December 18, 2012
Record last verified: 2012-12