proctitis
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time frame |
|---|---|
| improvement in endoscopic Mayo score 4 weeks after the intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| proportion of patients without relapse of rectal bleeding after 1 year of maintenance therapy | — |
Countries
Japan
Contacts
NTT Medical Center Tokyo Dept of Gastroenterology