Active Phase Study with MD-0901 -Phase 3 Clinical Trial in Patients with Mild to Moderate Active Ulcerative Colitis

Phase 3

• Conditions: Mild to moderate active ulcerative colitis

• Registration Number: JPRN-jRCT2080221343
• Lead Sponsor: MOCHIDA PHARMACEUTICAL CO., LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-01-06
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 228

Inclusion Criteria

1)Subjects who are diagnosed as ulcerative colitis
2)Subjects who are total score of 4-10 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, abnormal electrolyte metabolism disorder or hypersensitivity as complication
5)Subjects with malignant tumor as complication
etc.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy<br>Change from baseline in UC-DAI score<br>Safety<br>Adverse events<br><br>Efficacy<br>To assess the change in UC-DAI score from baseline to the end of treatment<br>Safety<br>To assess the incidence of adverse events

Secondary Outcome Measures

Name	Time	Method
Efficacy<br>1)Remission <br>2)Clinical Remission<br>3)Endoscopic Remission<br>4)Improvement<br>5)Change from baseline in each UC-DAI sub scale<br>Safety<br>The adverse events and adverse drug reactions<br><br>Efficacy<br>Item1)-4)<br>To assess the percentage of subjects in each secondary endpoint<br>Item5)<br>To assess the change in each UC-DAI sub scale from baseline to the end of treatment<br>Safety<br>To assess the incidence of the adverse events and adverse drug reactions