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Treatment of Cholestatic Pruritus With Sertraline

Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
Overall Status
Completed
CT.gov ID
NCT00058903
Collaborator
(none)
40
Enrollment
1
Location
23
Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this study is to find an effective and well-tolerated medical therapy for itching due to liver disease. Persons with primary biliary cirrhosis or chronic hepatitis C are currently being enrolled in the study. Persons participating in the study are given sertraline, a medication which is also often used for depression,to treat their itching. The dose is gradually increased as the effect on itching and any other potential side effects are carefully monitored.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Treatment of Cholestatic Pruritus With Sertraline
Study Start Date :
Apr 1, 2003
Study Completion Date :
Mar 1, 2005

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    • Itching for at least 3 months

    • Primary biliary cirrhosis or hepatitis C

    • Elevated alkaline phosphatase for at least 6 months

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Texas Southwestern Medical Center at Dallas Dallas Texas United States 75390

    Sponsors and Collaborators

    • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00058903
    Other Study ID Numbers:
    • TRCPWS (completed)
    First Posted:
    Apr 16, 2003
    Last Update Posted:
    Jan 13, 2010
    Last Verified:
    Jan 1, 2010
    Keywords provided by , ,
    Cholestatic
    Pruritus
    Sertraline
    primary biliary cirrhosis
    hepatitis C
    Additional relevant MeSH terms:
    Hepatitis C
    Hepatitis
    Liver Cirrhosis
    Liver Cirrhosis, Biliary
    Pruritus
    Fibrosis
    Sertraline

    Study Results

    No Results Posted as of Jan 13, 2010