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

Japan Familial adenomatous polyposis prevention study: Randomized controlled trial by low-dose aspirin - Japan Familial adenomatous polyposis prevention study: Randomized controlled trial by low-dose aspirin (J-FAPP Study 2)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000000698
Enrollment
70
Registered
2007-05-02
Start date
2007-05-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Familial adenomatous polyposis

Interventions

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

Sponsors

Basic and clinical researches on the development of chemopreventive drugs
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: # Patients with previous or existing 100 or more colorectal adenomas, or those with detrimental APC gene # Patients with at least 2 cm of rectal mucosa left intact # Patients who are able to undergo colonoscopy every 6 months # Japanese

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
Only a reduction in the number of rectal tumors is regarded as the event.

Countries

Japan

Contacts

Public ContactHideki Ishikawa

Kyoto Prefectural University of Medicine Department of Molecular-Targeting Cancer Prevention

06-6445-5585

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026