NCT00272324已完成2 期
Aspirin/Folate Prevention of Large Bowel Polyps
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,121
- 试验地点
- 10
- 主要终点
- 1 or more adenomas
研究概览
简要总结
This is a randomized controlled trial of aspirin and/or folate supplementation for the prevention of the recurrence of neoplastic polyps (adenomas) of the large bowel.
详细描述
This is a randomized controlled trial of aspirin and/or folate supplementation for the prevention of the recurrence of neoplastic polyps (adenomas) of the large bowel among subjects with a recent history of these tumors. The study is a randomized, double-blind, placebo-controlled trial with a 2 x 3 factorial design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •One neoplastic polyp removed within three months of study entry or within 16 months of study entry if over 1 cm in size or if subject has had a lifetime history of at least two polyps, with the entire large bowel seen by colonoscopy to be free of further polyps within 3 months of entry.
- •An ability and willingness to follow the study protocol, as indicated by the subject's giving informed consent to participate.
- •Good general health, with no severely debilitating diseases or active malignancy that might compromise the patient's ability to complete the study.
- •Anticipated colonoscopic follow-up three years after the qualifying colonoscopy.
- •Age between 21 and 80 years at the time of the intake colonoscopy.
- •For women of childbearing potential, agreement to use effective birth control for the duration of the study.
- •Intent not to take aspirin or aspirin-containing products, NSAIDs or folic acid for the length of the study unless required by a physician.
- •Not randomized previously or currently in a chemoprevention trial, except for the: "Nutritional Prevention of Large Bowel Polyps" Study (Polyps Prevention Study I); and brief participation in the "VA Cooperative Study" with no continuing involvement.
排除标准
- •Invasive carcinoma in any colonic polyp removed.
- •Familial colonic polyposis syndromes.
- •Ulcerative colitis or Crohn's disease.
- •Malabsorption syndrome (e.g. pancreatic insufficiency).
- •Large bowel resection for any reason.
- •Diagnosed narcotic or alcohol dependence
- •Contraindication to aspirin use, including:
- •documented peptic ulcer disease in the past 20 years
- •aspirin sensitivity
- •bleeding diathesis, including hemorrhagic stroke
- •Likelihood of NSAID use
- •recurring arthritis or other musculo-skeletal problems
- •frequent NSAID use in 5 years preceding
- •history of stroke or TIAs
- •history of angina or myocardial infarction
- •desire to take aspirin for the prevention of cardiovascular disease
- •Required or contraindicated folic acid use pernicious anemia or folic acid deficiency
- •Pregnancy or lactation.
结局指标
主要结局
1 or more adenomas
时间窗: For aspirin: follow-up years 1-3; For folate: follow-up years 1-3 and years 4-8
colorectal adenomas detected at follow-up colonoscopy
次要结局
- number of adenomas(For aspirin: follow-up years 1-3; For folate: follow-up years 1-3 and years 4-8)
- 1 or more advanced lesions(For aspirin: follow-up years 1-3; For folate: follow-up years 1-3 and years 4-8)
研究者
研究点 (10)
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