Ulcerative colitis in remission phase
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 in remission (defined as the Ulcerative Colitis Disease Activity Index (UC-DAI) score of 2 or less and a rectal bleeding score of 0) 3)Outpatients
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy Rectal bleeding Safety Adverse events Efficacy To assess the percentage of subjects in rectal bleeding non-occurrence Safety To assess the incidence of adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy 1)Duration for non-incidence of rectal bleeding period 2)Relapse 3)Change from baseline in UC-DAI score 4)Change from baseline in each UC-DAI sub scale Safety The adverse events and adverse drug reactions Efficacy Item 1) To assess duration for non-incidence of rectal bleeding period Item 2) To assess the percentage of subjects in relapse Item3)-4) To assess the change in UC-DAI or each UC-DAI sub scale from baseline score to the end of treatment Safety To assess the incidence of adverse events and adverse drug reactions | — |
Outcome results
None listed