- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00058903
Treatment of Cholestatic Pruritus With Sertraline
January 12, 2010 updated by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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Dallas, Texas, United States, 75390
- University of Texas Southwestern Medical Center at Dallas
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
- Itching for at least 3 months
- Primary biliary cirrhosis or hepatitis C
- Elevated alkaline phosphatase for at least 6 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2003
Study Completion
March 1, 2005
Study Registration Dates
First Submitted
April 14, 2003
First Submitted That Met QC Criteria
April 15, 2003
First Posted (ESTIMATE)
April 16, 2003
Study Record Updates
Last Update Posted (ESTIMATE)
January 13, 2010
Last Update Submitted That Met QC Criteria
January 12, 2010
Last Verified
January 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Skin Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Skin Manifestations
- Biliary Tract Diseases
- Bile Duct Diseases
- Cholestasis, Intrahepatic
- Cholestasis
- Fibrosis
- Hepatitis
- Hepatitis C
- Liver Cirrhosis
- Pruritus
- Liver Cirrhosis, Biliary
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Sertraline
Other Study ID Numbers
- TRCPWS (completed)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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