PS-SP PhaseIII Clinical Study; Investigation to find new formulation of mesalazine for treatment of patients with active Ulcerative Colitis.
Phase 3
- Conditions
- lcerative Colitis
- Registration Number
- JPRN-jRCT2080221382
- Lead Sponsor
- Kyorin Pharmaceutical Co.,LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
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 active phase when investigational drug is initially administered.
etc.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Endoscopic activity score
- Secondary Outcome Measures
Name Time Method C-DAI score, others.