Treatment of Cholestatic Pruritus With Sertraline

Hepatitis C Clinical Trial

Official title:

Treatment of Cholestatic Pruritus With Sertraline

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00058903
• Other study ID #: TRCPWS (completed)
• Status: Completed
• Phase: Phase 2
• First received: April 14, 2003
• Last updated: January 12, 2010
• Start date: April 2003
• Est. completion date: March 2005

Study information

• Verified date: January 2010
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

• Itching for at least 3 months

• Primary biliary cirrhosis or hepatitis C

• Elevated alkaline phosphatase for at least 6 months

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis C
• Liver Cirrhosis
• Liver Cirrhosis, Biliary
• Pruritus

Intervention

Drug:
• sertraline

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center at Dallas	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States,