Treatment of Cholestatic Pruritus With Sertraline | NCT00058903

Studies
Treatment of Cholestatic Pruritus With Sertraline

NCT00058903

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Status

Completed

Last Update Posted

Jan 13, 2010Estimated

Enrollment

40Estimated

Phase

Phase 2

Conditions

Pruritus
Liver Cirrhosis, Biliary
Hepatitis C

Interventions

sertraline

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Apr 2003

Primary Completion Date

Not provided

Completion Date

Mar 2005

First Submitted Date

Apr 14, 2003

First Submission Date that Met QC Criteria

Apr 15, 2003

First Posted Date

Apr 16, 2003Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 12, 2010

Last Update Posted Date

Jan 13, 2010Estimated

Description Module

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Name	Type	Description	Arm Group Labels	Other Names
sertraline	Drug

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Texas Southwestern Medical Center at Dallas		Dallas	Texas	75390	United States

Condition Browse Module

MeSH Terms

ID	Term
D011537	Pruritus
D008105	Liver Cirrhosis, Biliary
D006526	Hepatitis C

Ancestor Terms

ID	Term
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D012877	Skin Manifestations
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020280	Sertraline

Ancestor Terms

ID	Term
D015057	1-Naphthylamine
D000588	Amines
D009930	Organic Chemicals
D009281	Naphthalenes

Browse Leaves

Not provided

Browse Branches

Not provided