Active phase study of MD-0901 in pediatric ulcerative colitis.

Phase 2

Completed

• Conditions: Mildly to moderately active ulcerative colitis

• Registration Number: JPRN-jRCT2080223746
• Lead Sponsor: MOCHIDA PHARMACEUTICAL CO., LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-08
• Last Update Posted: 17 October 2023

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 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
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