Japan colorectal tumor prevention study: randomized controlled trial by low-dose aspirin

UMIN ID: UMIN000000697

Registered date:02/05/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: colorectal tumor
• Date of first enrollment: 2007/01/01
• Target sample size: 700
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Aspirin (100 mg/day) enteric-coated tablet
Placebo tablet / day

Outcome(s)

• Primary Outcome: Only the occurrence of a colorectal tumor (adenoma or cancer) is selected as the primary endpoint.

Key inclusion & exclusion criteria

• Age minimum: 40years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude criteria: # Patients with a medical history of submucosal or deeper colorectal cancer. # Patients currently taking antithrombotics such as Bayaspirin, Bufferin, Panaldine, Warfarin and Persantin. # Patients who have undergone colorectal resection (those who have undergone appendectomy are allowed to participate in the study). # Patients with familial colorectal adenoma. # Patients with a history of treatment of gastric or duodenal ulcer (those with successful eradication of Helicobacter pylori and ulcer resolution at S2 are allowed to participate in the study) # Patients with bleeding tendency, a platelet count of 150,000, or with abnormal PT # Patients with any existing cancer at the time of participation in the study. # Patients with known allergy to aspirin. # Patients currently taking anticancer drugs. # Women who are or may be pregnant during the study period. # Patients currently taking NSAIDs at least 3 times weekly, for example, as a analgesic.

Related Information

• Primary Sponsor: Basic and clinical researches on the development of chemopreventive drugs
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare Third Research Project on General Strategy Against Cancer