NCT00282386已完成3 期
A Multicenter, Randomized, Parallel-Group, Placebo-Controlled, Double-Blind Study With In-House Blinding to Determine the Effect of 156 Weeks of Treatment With MK0966 on the Recurrence of Neoplastic Polyps of the Large Bowel in Patients With a History of Colorectal Adenomas
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,586
- 主要终点
- Cumulative colorectal adenoma recurrence during treatment in patients with an increased risk to develop colorectal cancer.
研究概览
简要总结
This study was to compare the effect of 156 weeks of treatment with MK-0966 (Rofecoxib) versus placebo on the recurrence of colorectal adenomas (growths that occur on the inside (the lining) of the large intestine, also known as the colon) in patients with a history of colorectal adenomas.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible patients must have undergone a complete colonoscopy within 12 weeks of study entry with removal of all polyps; at least one polyp must have been confirmed a large bowel pre-cancerous polyp (adenoma) by the study pathologist.
排除标准
- •History with a specific hereditary large bowel polyp syndrome
- •History of a large bowel adenoma before age 35
- •Small or large bowel resection or history of inflammatory bowel disease
- •History of cancer within the five years before enrollment
- •Expected need for chronic NSAID therapy
- •Positive test result for stool occult blood
- •Uncontrolled hypertension, stroke or temporary mini stroke (TIA) within the past 2 years, angina or congestive heart failure with symptoms that occur at rest or with minimal activity
- •History of myocardial infarction (heart attack), coronary angioplasty, or coronary artery bypass grafting within the past 1 year
- •Pregnancy
结局指标
主要结局
Cumulative colorectal adenoma recurrence during treatment in patients with an increased risk to develop colorectal cancer.
时间窗: 156 Weeks
次要结局
- To evaluate safety & tolerability of rofecoxib
- Cumulative colorectal adenoma recurrence during treatment in patients with a history of colorectal adenoma(156 Weeks)
- Cumulative colorectal adenoma recurrence during treatment in all patients(52 Weeks)
研究者
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