Study of Gammalinolenic Acid for Juvenile Rheumatoid Arthritis - Tabular View

Tracking Information

First Received Date ^ICMJE

October 18, 1999

Last Updated Date

June 23, 2005

Start Date ^ICMJE

September 1994

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00004420 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Study of Gammalinolenic Acid for Juvenile Rheumatoid Arthritis

Official Title ^ICMJE

Brief Summary

OBJECTIVES:

I. Determine the efficacy and safety of gammalinolenic acid in the treatment of childhood arthritis.

Detailed Description

PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, cross over study of 12 months duration. Patients are stratified by type of juvenile rheumatoid arthritis (systemic onset vs pauciarticular disease vs polyarticular disease).

Patients are randomized to receive either gammalinolenic acid (GLA) or placebo (safflower seed oil) orally. Parents are asked to maintain the child's usual diet over the course of study.

Patients are followed at 3, 6, 9, and 12 months during study and at 6 months thereafter.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study

Condition ^ICMJE

Juvenile Rheumatoid Arthritis

Intervention ^ICMJE

Drug: gamma-Linolenic acid

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

Enrollment ^ICMJE

Completion Date

August 1999

Primary Completion Date

Eligibility Criteria ^ICMJE

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Juvenile rheumatoid arthritis (systemic onset, pauciarticular disease, and polyarticular disease)
Active synovitis

--Prior/Concurrent Therapy--

No more than 2 concurrent nonsteroidal antiinflammatory drugs
No more than 2 concurrent second line agents (e.g., D-penicillamine, oral or injectable gold, antimalarials, methotrexate, sulfasalazine)
Must have started second line agent at least 3 months prior to study
Must be on stable doses of all medications for at least 1 month prior to study
Prior prednisone allowed if started at least 3 months prior to study

Gender

Both

Ages

1 Year to 15 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00004420

Responsible Party

Study ID Numbers ^ICMJE

199/13314, UMASS-H-2703, UMASS-FDR001067

Study Sponsor ^ICMJE

FDA Office of Orphan Products Development

Collaborators ^ICMJE

University of Massachusetts

Investigators ^ICMJE

Study Chair:

Robert B. Zurier

University of Massachusetts

Information Provided By

FDA Office of Orphan Products Development

Verification Date

January 2000

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP