NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Ulcerative Colitis
Date of first enrollment	18/02/2011
Target sample size
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : PS-SP INN of investigational material : Therapeutic category code : 239 Other agents affecting digestive organs Dosage and Administration for Investigational material : PS-SP suppository 1g or placebo is administered rectally once a day.

Outcome(s)

Primary Outcome	Endoscopic activity score
Secondary Outcome	UC-DAI score, others.

Key inclusion & exclusion criteria

Age minimum	>= 15age old
Age maximum	<= 74age old
Gender	Both
Include 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.
Exclude 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.