Japan Familial adenomatous polyposis prevention study: Randomized controlled trial by low-dose aspirin

UMIN ID: UMIN000000698

Registered date:02/05/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Familial adenomatous polyposis
• Date of first enrollment: 2007/05/01
• Target sample size: 70
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: Only a reduction in the number of rectal tumors is regarded as the event.

Key inclusion & exclusion criteria

• Age minimum: 16years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude criteria: # Patients currently taking antithrombotics such as Bayaspirin, Bufferin, Panaldine, Warfarin and Persantin # Patients with gastric ulcer, small intestinal ulcer, anastomotic ulcer or colorectal ulcer # 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) # Confirmation method Each candidate patient should be interviewed to confirm that he or she has no medical history of gastric or duodenal ulcer and no pain in fasting state. Most recent GIF or UGI findings should be obtained as much as possible. # Patients with bleeding tendency, a platelet count of < 100,000, 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