ulcerative colitis
Conditions
Interventions
investigational material(s)
Generic name etc : PS-QD
INN of investigational material :
Therapeutic category code : 239 Other agents affecting digestive organs
Dosage and Administration for Investigat
Sponsors
Kyorin Pharmaceutical Co.,LTD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients meet the following criteria are to be enrolled in this study. -Patients who were diagnosed with ulcerative colitis. -Those who are in remission state when investigational drug is initially administered. etc.
Exclusion criteria
Exclusion criteria: Patients are not to be eligible for the study when they will fall into any of the following criteria. -Those who have a history of drug hypersensitivity to mesalazine or salicylic acid series -Those who have a history of serious hepatic and/or renal disorder, or those who are with serious hepatic and/or renal disorder -Those who have a history of serious cardiac, pulmonary, blood and/or pancreatic disorder, or those who are with serious cardiac, pulmonary, blood and/or pancreatic disorder etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The presence or absence of remission state | — |
Secondary
| Measure | Time frame |
|---|---|
| The period for remission state | — |
Outcome results
None listed