Mild to moderate active ulcerative colitis
Conditions
Sponsors
MOCHIDA PHARMACEUTICAL CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy Change from baseline in UC-DAI score Safety Adverse events Efficacy To assess the change in UC-DAI score from baseline to the end of treatment Safety To assess the incidence of adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy 1)Remission 2)Clinical Remission 3)Endoscopic Remission 4)Improvement 5)Change from baseline in each UC-DAI sub scale Safety The adverse events and adverse drug reactions Efficacy Item1)-4) To assess the percentage of subjects in each secondary endpoint Item5) To assess the change in each UC-DAI sub scale from baseline to the end of treatment Safety To assess the incidence of the adverse events and adverse drug reactions | — |
Outcome results
None listed