A Dose-finding Study of OPC-6535 in Patients With Active Ulcerative Colitis
Phase 2
Terminated
- Conditions
- Active ulcerative colitis
- Registration Number
- JPRN-jRCT2080220212
- Lead Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- terminated
- Sex
- All
- Target Recruitment
- 160
Inclusion Criteria
(1) Patients with active ulcerative colitis,
(2) Age: 18 to less than 65 years (at time of informed consent),
(3) Patients who have been receiving an oral 5-ASA formulation at a fixed regimen and at a fixed dose,
(4) Either inpatient or outpatient
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Clinical improvement rate after 8 weeks of study drug administration
- Secondary Outcome Measures
Name Time Method efficacy<br>1. Remission rate<br>2. Mean change from the baseline in total Disease Activity Index (DAI) score<br>3. Mean change from the baseline in DAI subscores <br>4. Mean change from the baseline in total Clinical Activity Index (CAI) score <br>5. Mean change from the baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) score<br>6. Mean change from the baseline in IBDQ subscale scores<br>7. Clinical improvement rate after 4 weeks of study drug administration