Active ulcerative colitis
Conditions
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients aged 16 years or older 2)Patients having an insufficient response to ASA oral formulation 3)Patients shown via colonoscopy to have major lesions between the sigmoid colon and rectum
Exclusion criteria
Exclusion criteria: 1. Patients who have a history of intestinal resection (other than appendiceal resection) 2. Patients who have a complication of malignant tumor 3. Female patients who are pregnant, lactating, or possibly pregnant, or who hope to become pregnant during the study period 4. Patients who have complications of serious cardiac, hepatic or renal impairment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety efficacy Efficacy: Clinical improvement rate, Safety: Adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy - Clinical remission: a decrease of the total Disease Activity Index [DAI] scores for "bloody stools" and "endoscopic findings" to 0 points [Time Frame: 6weeks] - Changes in the total DAI score [Time Frame: 6 weeks] - Changes in each DAI subscore [Time Frame: 2, 4, 6weeks] - Changes in the total Endoscopic Index (EI) score [Time Frame: 6 weeks] - Changes in each EI subscore [Time Frame: 6 weeks] | — |
Countries
Japan
Outcome results
None listed