NCT00844727终止2 期
Coxib-inhibition of Duodenal Polyp Growth in Familial Adenomatous Polyposis
Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2003年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 38
- 试验地点
- 1
研究概览
简要总结
Preliminary data indicate a protective effect on the development of duodenal polyps by coxib treatment. The hypothesis of the present study is that normal therapy doses of rofecoxib for 1 year would stop or reverse the development of premalignant adenomatous lesions in the duodenal mucosa of FAP patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •FAP patient with previous colectomy and confirmed polyposis
排除标准
- •Pregnancy
- •Malignancy
- •NSAID hypersensitivity
研究组 & 干预措施
1
Active Comparator
Rofexocib 25 mg OD, 1 year treatment
干预措施: Rofecoxib (Drug)
2
Placebo Comparator
Placebo
干预措施: placebo (Drug)
研究者
研究点 (1)
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