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Preliminary/exploratory study on the inhibitory effect of time-dependent mesalazine on the formation of polyps in patients with familial adenomatous polyposis

Preliminary/exploratory study on the inhibitory effect of time-dependent mesalazine on the formation of polyps in patients with familial adenomatous polyposis - Mesalazine polyp-inhibition study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000009363
Enrollment
6
Registered
2012-11-24
Start date
2012-11-24
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

6 months oral administration of time-dependent release mesalazine 4g/day (2g twice daily).

Sponsors

Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who need colonoscopic examination at least once a half year

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Comparison of the size of colorectal polyps post administration to that at baseline.

Secondary

MeasureTime frame
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).

Countries

Japan

Contacts

Public ContactHideki Ishikawa MD, PhD

Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Department of Molecular-Targeting Cancer Prevention

cancer@gol.com06-6202-5444

Outcome results

None listed

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