JPRN-jRCT2080223746
Completed
Phase 2
The clinical study to evaluate the efficacy, safety, and pharmacokinetics of MD-0901 in pediatric patients with mildly to moderately active ulcerative colitis.
MOCHIDA PHARMACEUTICAL CO., LTD0 sites26 target enrollmentDecember 8, 2017
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Mildly to moderately active ulcerative colitis
- Sponsor
- MOCHIDA PHARMACEUTICAL CO., LTD
- Enrollment
- 26
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(1\)Subjects who are diagnosed as ulcerative colitis
- •(2\)Subjects who are total score of 3\-8 on the Ulcerative Colitis Disease Activity Index (UC\-DAI) with a sigmoidoscopy score of 1 or higher, a rectal bleeding score of 1 or higher, and a Physician's Global Assessment (PGA) score of 2 or less at the baseline
- •(3\)Body weight 18\-90 kg at the baseline
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
Outcomes
Primary Outcomes
Not specified
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