Ulcerative colitis
Conditions
Interventions
Oral administration of Pentasa 4000mg/day
Sponsors
Dokkyo Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Mild to moderate, active ulcerative colitis. 2.Adult outpatients. 3.Disease extent, disease duration, disease course and gender: No limitation. 4.Patients treated with immunomodulators: constant or decreasing dosage within 90 days before registration, and expected no dose increase in observation period. 5.Agreement in writing about this study.
Exclusion criteria
Exclusion criteria: 1.Moderate, severe or fulminating active ulcerative colitis. 2.Use of oral 5-ASAs more than 4g/day within 2 weeks prior to study entry. 3.Introduce or increase the dosage of Steroids (intravenous infusion, oral), biologics or CAP within the last 90 days. 4.Increase the dosage of immunomodulators within the last 90 days. 5.Introduce or increase the treatment in the observation period. 6.Possible or documented pregnancy. 7.Experience of hypersensitivity to mesalazine. 8.Malignant disease or its history. 9.Patients who are considered inappropriate by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mucosal healing rate at 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Maintainance of remission with once-daily oral mesalazine in patients achieved mucosal healing. Effect of long-term administration of oral mesalazine in patients with persistent endoscopically active UC. | — |
Countries
Japan
Contacts
Public ContactKeiichi Tominaga
DOKKYO Medical University Gastroenterology
Outcome results
None listed