NCT00036283已完成2 期
Clinical Protocol For A Phase II Double-Blind, Placebo-Controlled, Randomized Study Of Celecoxib (Sc-58635) In Oral Premalignant Lesions, Investigator IND
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 42
- 试验地点
- 8
- 主要终点
- To evaluate the efficacy of celecoxib in subjects with Early or Advanced oral premalignant lesion (OPL)
研究概览
简要总结
Reduction in size and number of oral premalignant lesions
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •8mm oral premalignant lesion that has not been biopsied in the past 6 months
排除标准
- •Taking >100mg daily dose of NSAIDS (Non-steroidal anti-inflammatory drugs)
结局指标
主要结局
To evaluate the efficacy of celecoxib in subjects with Early or Advanced oral premalignant lesion (OPL)
by both clinical response (reduction in size of all lesions,
prevention of growth in the index lesion and of any new lesions)
and histological response (change in histological grade).
To evaluate the safety of chronic multiple dosing of celecoxib in this patient population.
次要结局
- To evaluate the treatment effects in modulating the expression of genomic and proliferative markers after 12 weeks of treatment with study drug, followed by 12 weeks off study drug.
研究者
研究点 (8)
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