Treatment of Cholestatic Pruritus With Sertraline - Tabular View

Tracking Information
First Received Date ^ICMJE	April 14, 2003
Last Updated Date	October 9, 2007
Start Date ^ICMJE	April 2003
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00058903 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Treatment of Cholestatic Pruritus With Sertraline
Official Title ^ICMJE	Treatment of Cholestatic Pruritus With Sertraline
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.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Pruritus Liver Cirrhosis, Biliary Hepatitis C
Intervention ^ICMJE	Drug: sertraline
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	40
Completion Date	March 2005
Primary Completion Date
Eligibility Criteria ^ICMJE	Itching for at least 3 months Primary biliary cirrhosis or hepatitis C Elevated alkaline phosphatase for at least 6 months
Gender	Both
Ages	21 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00058903
Responsible Party
Study ID Numbers ^ICMJE	TRCPWS
Study Sponsor ^ICMJE	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Verification Date	October 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP