Back to resultsTreatment of Cholestatic Pruritus With Sertraline
Primary Purpose
Pruritus, Liver Cirrhosis, Biliary, Hepatitis C
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
sertraline
Sponsored by
About this trial
This is an interventional treatment trial for Pruritus focused on measuring Cholestatic, Pruritus, Sertraline, primary biliary cirrhosis, hepatitis C
Eligibility Criteria
Itching for at least 3 months Primary biliary cirrhosis or hepatitis C Elevated alkaline phosphatase for at least 6 months
Sites / Locations
- University of Texas Southwestern Medical Center at Dallas
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00058903
First Posted
April 14, 2003
Last Updated
January 12, 2010
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT00058903
Brief Title
Treatment of Cholestatic Pruritus With Sertraline
Official Title
Treatment of Cholestatic Pruritus With Sertraline
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pruritus, Liver Cirrhosis, Biliary, Hepatitis C
Keywords
Cholestatic, Pruritus, Sertraline, primary biliary cirrhosis, hepatitis C
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
sertraline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Itching for at least 3 months
Primary biliary cirrhosis or hepatitis C
Elevated alkaline phosphatase for at least 6 months
Facility Information:
Facility Name
University of Texas Southwestern Medical Center at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
12. IPD Sharing Statement
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Treatment of Cholestatic Pruritus With Sertraline
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