Maintenance phase study of MD-0901 in pediatric ulcerative colitis.
Phase 2
Completed
- Conditions
- lcerative colitis in remission
- Registration Number
- JPRN-jRCT2080223747
- Lead Sponsor
- MOCHIDA PHARMACEUTICAL CO., LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 26
Inclusion Criteria
(1)Subjects who are diagnosed as ulcerative colitis
(2)Subjects who are total score of 2 or less on the Ulcerative Colitis Disease Activity Index (UC-DAI) with a rectal bleeding score of 0 at the baseline
(3)Body weight 18-90 kg at the baseline
etc
Exclusion Criteria
(1)Subjects with a history of colectomy (except appendectomy)
(2)Subjects with moderate/severe renal or liver impairment
(3)Subjects with serious blood disorder, respiratory disorder, digestive disorder, cardiovascular disorder, psychiatric disorder, abnormal electrolyte metabolism disorder or hypersensitivity as complication
(4)Subjects with malignant tumor as complication
etc
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method