Health Condition 1: null- Active distal ulcerative colitis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult patients 2. Mild-to-moderately active proctitis and proctosigmoiditis (Ulcerative Colitis Disease Activity Index [UCDAI] score, 3-9), with endoscopic disease extent up to 25 cm from the anal verge 3. Patients receiving mesalamine if the dose is stable for more than 8 weeks
Exclusion criteria
Exclusion criteria: 1. Patients receiving rectal mesalamine or steroids during last 4 weeks 2. Disease extent more than proctosigmoiditis, evidence of severe disease (UCDAI more than 10) 3. Steroid initiation/dose escalation within the past 2 weeks, 4. Azathioprine initiation in past 6 months or change in dose of azathioprine in last 3 months. 5. History of Patients started on mesalamine in the past 8 weeks. 6. Patients requiring hospitalization and imminent need for surgery 7. Lactating and pregnant women 8. Patients received any investigational medicines within 3 months 9. Patients with significant hepatic, renal, endocrine, respiratory, neurologic, or cardiovascular diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure was improvement in activity of UC. This was defined as a decrease in the UCDAI by equal or more than 3 from baselineTimepoint: 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures were proportion of patients achieving remission and mucosal healingTimepoint: 8 week | — |
Countries
India