Japan Familial adenomatous polyposis prevention study: Randomized controlled trial by low-dose aspirin and/or mesalazine

Phase 2

• Conditions: familial adenomatous polyposis

• Registration Number: JPRN-UMIN000018736
• Lead Sponsor: Kyoto Prefectural University of Medicine

Brief Summary

The crude odds ratio (95% confidence interval) was 0.43 (0.19-0.97) with aspirin administration. On the other hand, the crude odds ratio (95% confidence interval) of the mesalazine-administered group was 0.87 (0.39-1.96).In a low-dose aspirin administration clinical trial targeting unoperated FAP, it was clarified that the frequency of colorectal polyp growth, which is the main endpoint, can be safely suppressed.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-21
• Study Completion: 2018-12-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

Not provided

Exclusion Criteria

# Patients currently taking antithrombotics such as Bayaspirin, Panaldine, Warfarin and Persantin etc. # Patients who have undergone colorectal resection (those who have undergone appendectomy are allowed to participate in the study). # Patients with a history of stroke including transient ischemic attack. # 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 inflammatory bowel disease (ulcerative colitis, Crohn syndrome), bleeding diverticulosis, bleeding gastritis. # Patients with bleeding tendency, a platelet count of < 100,000 /mm3, or with abnormal prothrombin time, or white blood cell count of 3,000 /mm3. # Patients with any existing cancer at the time of participation in the trial, excluding radical cure of cancer, thyroid cancer and prostate cancer. # Patients currently taking anticancer drugs. # Patients with known allergy to aspirin or mesalazine. # Women who are or may be pregnant during the study period. # Patients currently taking NSAIDs at least 3 times weekly, for example, as an analgesic. # Patients who took NSAIDs, such as sulindac, for the purpose of cancer chemoprevention but not pass 6 months at the time of the trial start. (Patients taking a lactic acid products such as BIOLACTIS POWDER; are allowed to participate in the trial.)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is set as the incidence of recurrence / development of colorectal polyps that more than 5.0 mm in diameter after 8 months oral administration of low-dose aspirin and/or mesalazine.

Secondary Outcome Measures

Name	Time	Method
Maximum diameter and histology of the colorectal polyps more than 5.0 mm in size after 8 months oral administration of low-dose aspirin and/or mesalazine. The change of all the number of the colorectal polyps smaller than 5.0 mm in diameter are compared between pre and post administration of low-dose aspirin and/or mesalazine. (The changes of polyp number are assessed by at least three medical specialists for colon endoscopy in a blinded manner with several endoscopic photographs in the cecum, the splenic flexure and the lower part of the rectum.) The change of number of the upper gastrointestinal tumor, such as gastric adenoma and duodenal adenoma, are compared between pre and post administration of low-dose aspirin and/or mesalazine. The occurrence of adverse events. The incidence of recurrence /development of colorectal polyps more than 5.0 mm in diameter at 8-12 months after cessation of administration of low-dose aspirin and/or mesalazine.