Application of COX-2 Inhibitor for Treatment of Primary Hypertrophic Osteoarthropathy
试验速览
- 阶段
- 3 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Prostaglandin E2（PGE2） level change after COX-2 inhibitor treatment in PHO patients
研究概览
简要总结
The purpose of this study is to determine whether COX-2 inhibitor is effective in the treatment of primary hypertrophic osteoarthropathy
详细描述
Patients with primary hypertrophic osteoarthropathy(PHO) were diagnosed based on clinical manifestations and symptoms. PHO patients were treated with COX-2 inhibitor after signing informed consent. The extend of alleviation, the change of the markers on prostaglandin E metabolic pathway and the adverse event on different time points were recorded to identify the efficacy and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •diagnosed with primary hypertrophic osteoarthropathy clinically
- •over 16 years old
- •no other medication intake
- •informed consent signed
排除标准
- •below 16 years old
- •active gastric ulcer
- •inflammatory bowel disease
- •New York Heart Association classification（NYHA） II to IV
- •liver or renal failure
- •allergic to nonsteroid anti-inflammatory drugs
- •not willing to participate
研究组 & 干预措施
COX-2 Inhibitor
Patients who take COX-2 inhibitor
干预措施: COX-2 inhibitor (Drug)
结局指标
主要结局
Prostaglandin E2（PGE2） level change after COX-2 inhibitor treatment in PHO patients
时间窗: 3 months
measure the serum prostaglandin E2 level at 3 months
Prostaglandin E2（PGE2） level change after COX-2 inhibitor treatment in PHO
时间窗: 6 months
measure the serum prostaglandin E2 level at 6 months
次要结局
- change in pain on VAS scale after COX-2 inhibitor treatment(12 months)
- The volume of distal part of middle finger change after COX-2 inhibitor treatment(12 months)
- Circumference of knee joint change after COX-2 inhibitor treatment(12 months)