Treatment of Cholestatic Pruritus With Sertraline

NCT ID: NCT00058903

Last Updated: 2010-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-04-30
• Study Completion Date: 2005-03-31

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.

Conditions

Pruritus; Liver Cirrhosis, Biliary; Hepatitis C

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

sertraline

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Itching for at least 3 months
• Primary biliary cirrhosis or hepatitis C
• Elevated alkaline phosphatase for at least 6 months

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: lead

Locations

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, United States

Countries

United States

Other Identifiers

TRCPWS (completed)

Identifier Type: -

Identifier Source: org_study_id