Z-206 Phase III Clinical Trial - Investigation on the remission-maintaining effect in patients with ulcerative colitis in remission phase
- Conditions
- Patients with ulcerative colitis in remission phase.
- Registration Number
- JPRN-C000000289
- Lead Sponsor
- Zeria Pharmaceutical Co.,LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 120
Not provided
1)Patients who take adrenal corticosteroid (oral formulation, enemas, suppository, agents for hemorrhoidal problem, injectable solution) within 14 days before start of administration of clinical study drug. 2)Patients who are administered immune-suppressing drug before start of administration of clinical study drug within 90 day. 3)Patients who are treated by blood cell apheresis within 14 days before start of administration of clinical study drug. 4)Patients with history of drug hypersensitivity to mesalazine formulation and drugs of salicylic acid groups. 5)Patients with liver disease or kidney disease (Each clinician will judge the presence or absence of liver disease or kidney disease.) 6)Patients with serious cardiovascular disease, hemodyscrasia or lung disease, or patients with history of serious cardiovascular disease, hemodyscrasia or lung disease. 7)Patients with malignant tumor as complication. 8)Pregnants, females who suckles, or females who wish to become pregnant. 9)Patients who are administered some kinds of clinical study drug within 6 months before obtaining informed consent. The clinical study drug administered in
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method on-incidence of bloody stool
- Secondary Outcome Measures
Name Time Method Period of non-emergence of bloody stool. Non-recurrence rates. Period of non-recurrence of bloody stool, and change of UC-DAI.