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Study on the efficacy of 5ASA oral formula and suppository against relapse of proctitis

Study on the efficacy of 5ASA oral formula and suppository against relapse of proctitis - Oral vs. suppository 5ASA against relapse of proctitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000014838
Enrollment
140
Registered
2014-08-12
Start date
2014-08-12
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

proctitis

Interventions

asacol 3.6g t.i.d 4 weeks pentasa suppository 1g/day 4 weeks

Sponsors

NTT Medical Center Tokyo
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Having been diagnosed as proctitis by colonoscopy more than 6 months before Having been on maintenance therapy with oral 5ASA (2.4g/day or less), oral sulfasalazine (3g/day or less), sulfasalazine suppository, or 5ASA suppository(1 in two days or less), or no maintenance therapy, which has not been changed for at least 2 months prior to the study entry Bleeding Mayo score > 0 Given written informed consent Eendoscopic Mayo score > 0 No active inflammation in area more than 15cm from the anal verge on colonoscopy

Exclusion criteria

Exclusion criteria: Pregnant or nursing female Patients who received steroids, immunosuppressants, immunomodulators, anti-TNF alpha, or leucocytapheresis within 3 months before the study entry Those with severe liver or renal dysfunction Those with a history of hypersensitivity against mesalazine Those who were regarded inadequate for this study

Design outcomes

Primary

MeasureTime frame
improvement in endoscopic Mayo score 4 weeks after the intervention

Secondary

MeasureTime frame
proportion of patients without relapse of rectal bleeding after 1 year of maintenance therapy

Countries

Japan

Contacts

Public ContactNobuyuki Matsuhashi

NTT Medical Center Tokyo Dept of Gastroenterology

nmatuha-tky@umin.ac.jp03-3448-6245

Outcome results

None listed

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