Treatment of Cholestatic Pruritus With Sertraline

This study has been completed.

Sponsored by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00058903

Purpose

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	Intervention	Phase
Pruritus Liver Cirrhosis, Biliary Hepatitis C	Drug: sertraline	Phase II

MedlinePlus related topics: Cirrhosis Hepatitis Hepatitis C Itching

Drug Information available for: Sertraline hydrochloride Sertraline

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Official Title:	Treatment of Cholestatic Pruritus With Sertraline

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Estimated Enrollment:	40
Study Start Date:	April 2003
Estimated Study Completion Date:	March 2005

Eligibility

Ages Eligible for Study:	21 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00058903

Locations

United States, Texas
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)

More Information

Study ID Numbers:	TRCPWS
Study First Received:	April 14, 2003
Last Updated:	October 9, 2007
ClinicalTrials.gov Identifier:	NCT00058903
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Cholestatic
Pruritus
Sertraline
primary biliary cirrhosis
hepatitis C

Study placed in the following topic categories:

Biliary cirrhosis
Pruritus
Liver Diseases
Skin Diseases
Fibrosis
Cholestasis
Hepatitis, Viral, Human
Liver Cirrhosis
Serotonin
Hepatitis

Virus Diseases
Signs and Symptoms
Digestive System Diseases
Cholestasis, Intrahepatic
Bile Duct Diseases
Biliary Tract Diseases
Sertraline
Hepatitis C
Primary biliary cirrhosis
Liver Cirrhosis, Biliary

Additional relevant MeSH terms:

Skin Manifestations
RNA Virus Infections
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Flaviviridae Infections
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs

Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Agents
Pathologic Processes
Therapeutic Uses
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 16, 2009