Preliminary/exploratory study on the inhibitory effect of time-dependent mesalazine on the formation of polyps in patients with familial adenomatous polyposis
Phase 2
- Conditions
- Familial adenomatous polyposis
- Registration Number
- JPRN-UMIN000009363
- Lead Sponsor
- Graduate School of Medical Science, Kyoto Prefectural University of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 6
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients who take mesalamine or sulphasalazine within two weeks before the registration. 2) Patients who have possibility to take NSAIDs (non-steroidal anti-inflammatory drugs) constantly during the study period. 3) Patients who have high possibility to be applied colectomy during the study period. 4) Patients with hypersensitivity to salicylic acid drug or mesalazine formulations. 5) Patients who have experienced serious adverse events due to mesalazine. 6) Women who are or may be pregnant during the study period. 7) Patients with side effects by other previous clinical studies. 8) Patients who were considered unsuitable for this study by investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of the size of colorectal polyps post administration to that at baseline.
- Secondary Outcome Measures
Name Time Method Below items are compared between pre and post administration of mesalazine. number of colorectal polyps, sites of polyps, adverse events, size and number of polyps (fundic gland polyp, gastric adenoma (gastric, intestinal type), duodenal adenoma, thyroid tumor, gallbladder polyp, desmoids).