NCT00004288已完成2 期
Phase II Pilot Study of Olsalazine for Ankylosing Spondylitis
National Center for Research Resources (NCRR)0 个研究点目标入组 4 人开始时间: 1996年5月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 4
研究概览
简要总结
OBJECTIVES:
I. Assess the safety and efficacy of olsalazine, a dimer of 5-aminosalicylic acid, in men with ankylosing spondylitis unresponsive to nonsteroidal anti-inflammatory drugs and physiotherapy.
详细描述
PROTOCOL OUTLINE: Patients are treated with daily olsalazine. The dose is increased each week until the protocol dose is reached.
Supplemental acetaminophen is allowed; nonsteroidal anti-inflammatory drugs continue unchanged. Concurrent sulfasalazine is prohibited.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •PROTOCOL ENTRY CRITERIA:
- •-Disease Characteristics--
- •Meets modified New York diagnostic criteria
- •Active disease, i.e., morning stiffness for more than 30 minutes
- •Failed or experienced nonlife-threatening reaction to prior sulfasalazine
- •No significant hematologic, hepatic, or renal disease
排除标准
- 未提供
研究组 & 干预措施
未命名试验
干预措施: olsalazine (Drug)
研究者
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