Ignite Creation Date:
2024-05-05 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 9:55 AM
Study NCT ID:
NCT00756171
Status:
COMPLETED
Last Update Posted:
2012-12-18
First Post:
2008-09-18
Brief Title:
Colesevelam Versus Placebo in Cholestatic Pruritus
Sponsor:
Foundation for Liver Research
Organization:
Foundation for Liver Research
Study Overview
Official Title:
Colesevelam Versus Placebo in Cholestatic Pruritus A Double-blind Placebo-controlled Study
Status:
COMPLETED
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COPE
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None