Treatment of Cholestatic Pruritus With Sertraline

This study has been completed.

First Received on April 14, 2003. Last Updated on January 12, 2010 History of Changes

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Treatment of Cholestatic Pruritus With Sertraline

Resource links provided by NLM:

Genetics Home Reference related topics: North American Indian childhood cirrhosis progressive familial intrahepatic cholestasis

MedlinePlus related topics: Cirrhosis Hepatitis Hepatitis A Hepatitis C Itching

Drug Information available for: Sertraline hydrochloride Sertraline

U.S. FDA Resources

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

No publications provided

ClinicalTrials.gov Identifier:	NCT00058903 History of Changes
Other Study ID Numbers:	TRCPWS (completed)
Study First Received:	April 14, 2003
Last Updated:	January 12, 2010
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

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis C
Liver Cirrhosis
Fibrosis
Liver Cirrhosis, Biliary
Pruritus
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

Pathologic Processes
Cholestasis, Intrahepatic
Cholestasis
Bile Duct Diseases
Biliary Tract Diseases
Skin Diseases
Skin Manifestations
Signs and Symptoms
Sertraline
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012