Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004420
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
1999-10-18
Brief Title:
Study of Gammalinolenic Acid for Juvenile Rheumatoid Arthritis
Sponsor:
FDA Office of Orphan Products Development
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
OBJECTIVES
I Determine the efficacy and safety of gammalinolenic acid in the treatment of childhood arthritis
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 childs usual diet over the course of study
Patients are followed at 3 6 9 and 12 months during study and at 6 months thereafter
Patients are randomized to receive either gammalinolenic acid GLA or placebo safflower seed oil orally Parents are asked to maintain the childs 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UMASS-FDR001067 | None | None | None |
| UMASS-H-2703 | None | None | None |