NCT00585312终止3 期
A Phase III Placebo-Controlled Trial Of Celecoxib In Genotype Positive Subjects With Familial Adenomatous Polyposis
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2006年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Time to Disease Progression
研究概览
简要总结
To test whether celecoxib can be used to prevent colon polyp formation in children with familial adenomatous polyposis (FAP).
详细描述
Per DMC recommendation, the study was terminated early (31Oct2013) due to low enrollment and low endpoint accumulation rate. No safety concerns were involved in the decision to terminate the study.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 10-17 years
- •Confirmed deleterious FAP genotype based on central genetic testing or personal history ot >2 colorectal adenomas and a parent with the diagnosis of FAP and either A, B or C below A: Non-attenuated FAP genotype B: Attenuated FAP genotype and a personal history of colorectal adenomas and a first degree relative with FAP C: No genotype identified with a personal history of > 2 adenomas and have a parent with FAP
- •Less than 30 polyps, which need to be removed to render the colon polyp-free before study drug can be given
排除标准
- •Diagnosis of attenuated FAP based on central genetic testing in the absence of a personal history of >2 colorectal adenomas and a first degree relative (parent or sibling) with FAP.
- •Sensitivity to COX-2 inhibitors
研究组 & 干预措施
Celecoxib
Experimental
celecoxib, 16 mg/kg/day, for 5 years
干预措施: Celecoxib (Drug)
Placebo
Placebo Comparator
Masked, placebo comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Time to Disease Progression
时间窗: 5 years
Time to disease progression was defined as the time from randomization to the earliest occurrence of one or more of the following events: 1. Appearance of ≥20 polyps (\>2 mm in size) at any colonoscopy during the study (Polyps); or 2. Diagnosis of colorectal malignancy (ColMal).
次要结局
- Time to Treatment Failure(5 years)
- Total Number of Colorectal Polyps(Years 1 - 5)
- Colorectal Polyp Burden(Years 1 - 5)
研究者
研究点 (1)
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