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Study of Gammalinolenic Acid for Juvenile Rheumatoid Arthritis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004420
First Posted: October 19, 1999
Last Update Posted: March 25, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Massachusetts, Worcester
Information provided by:
FDA Office of Orphan Products Development
  Purpose

OBJECTIVES:

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


Condition Intervention
Juvenile Rheumatoid Arthritis Drug: gamma-Linolenic acid

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment: 50
Study Start Date: September 1994
Estimated Study Completion Date: August 1999
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  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): NCT00004420


Sponsors and Collaborators
FDA Office of Orphan Products Development
University of Massachusetts, Worcester
Investigators
Study Chair: Robert B. Zurier University of Massachusetts, Worcester
  More Information

ClinicalTrials.gov Identifier: NCT00004420     History of Changes
Other Study ID Numbers: 199/13314
UMASS-H-2703
UMASS-FDR001067
First Submitted: October 18, 1999
First Posted: October 19, 1999
Last Update Posted: March 25, 2015
Last Verified: January 2000

Keywords provided by FDA Office of Orphan Products Development:
arthritis & connective tissue diseases
juvenile rheumatoid arthritis
rare disease

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Efamol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Dermatologic Agents