NCT00004420已完成不适用
Study of Gammalinolenic Acid for Juvenile Rheumatoid Arthritis
FDA Office of Orphan Products Development0 个研究点目标入组 50 人开始时间: 1994年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
研究概览
简要总结
OBJECTIVES:
I. Determine the efficacy and safety of gammalinolenic acid in the treatment of childhood arthritis.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 1 Year 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究者
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