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Treatment of Cholestatic Pruritus With Sertraline

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ClinicalTrials.gov Identifier: NCT00058903
Recruitment Status : Completed
First Posted : April 16, 2003
Last Update Posted : January 13, 2010
Sponsor:
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Pruritus Liver Cirrhosis, Biliary Hepatitis C Drug: sertraline Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Cholestatic Pruritus With Sertraline
Study Start Date : April 2003
Estimated Study Completion Date : March 2005


Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00058903     History of Changes
Other Study ID Numbers: TRCPWS (completed)
First Posted: April 16, 2003    Key Record Dates
Last Update Posted: January 13, 2010
Last Verified: January 2010

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 C
Fibrosis
Liver Cirrhosis
Pruritus
Liver Cirrhosis, Biliary
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Pathologic Processes
Skin Diseases
Skin Manifestations
Signs and Symptoms
Cholestasis, Intrahepatic
Cholestasis
Bile Duct Diseases
Biliary Tract Diseases
Sertraline
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs