Phase 3 Clinical Trial with MD-0901

Phase 3

• Conditions: Mild to moderate active ulcerative colitis

• Registration Number: JPRN-jRCT2080222425
• Lead Sponsor: MOCHIDA PHARMACEUTICAL CO., LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-17
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 250

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)Outpatients

Exclusion Criteria

1)Subjects who are classified to severe ulcerative colitis by severity classification
2)Subjects with a history of colectomy (except appendectomy)
3)Subjects with moderate/severe renal or liver impairment
4)Subjects with serious blood disorder, respiratory disorder, digestive disorder, cardiovascular disorder, psychiatric disorder, metabolic and electrolyte abnormality or hypersensitivity as complication
5)Subjects with malignant tumor as complication
etc.

Study & Design

• Study Type: Interventional
• Study Design: Not specified