J-FAPP Study V

Phase 2

Recruiting

• Conditions: Familial adenomatous polyposis; Hereditary, polyposis, APC gene; D126 (CJHJ)

• Registration Number: JPRN-jRCTs031210443
• Lead Sponsor: Mutoh Michihiro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1) Patients with familial adenomatous polyposis.
2) No colectomy (Except for an appendectomy).
3) Those who have had all colorectal polyps of 5.0 mm or more removed endoscopically and no remaining polyps of 5.0 mm or more.
4)16 to 70 years old (regardless of sex)
5) The patient has given written consent prior to enrollment in this study.

Exclusion Criteria

Those who fall under any of the following are not included in this study.
1) Those who are currently taking antithrombotic agents and anticoagulants (trade names: biaspyrin, bufferin, panaldine, warfarin, persantin, etc.).
2) A history of stroke (transient ischemic attack: including TIA).
3) Patients with a history of treatment for gastric ulcer and duodenal ulcer . (Those who have confirmed S2 healing of ulcers after successful eradication of Helicobacter pylori, can participate)
4) Easy occurrence of inflammatory bowel disease (ulcerative colitis, Crohn's disease), hemorrhagic diverticulitis, severe hemorrhagic gastritis, etc.
5) Those with bleeding tendency, platelet count 100,000 / ul or less, white blood cell 3,000 / ul or less.
6) A person with a malignant tumor that is progressive or requires treatment at the time of entry. (except undergone curative resection).
7) Those who are undergoing anti-cancer drug treatment or radiation therapy.
8) Those who have a history of allergies to aspirin or the preparation of salicylic acid.
9) Those who are pregnant and plan to become pregnant during the study period.
10) Those who take NSAIDs at least 3 times a week for pain relief.
11) Those who took sulindac for the purpose of reducing polyps, but not have passed 6 months after stopping it.
12) Smokers (including heated cigarettes)

Study & Design

• Study Type: Interventional
• Study Design: Not specified