NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	ulcerative colitis
Date of first enrollment	09/12/2009
Target sample size
Countries of recruitment
Study type	Interventional
Intervention(s)	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 Investigational material : Mesalazine at the dose 1500mg/day or 2250mg/day is administered once a day or three times a day.

Outcome(s)

Primary Outcome	The presence or absence of remission state
Secondary Outcome	The period for remission state

Key inclusion & exclusion criteria

Age minimum	>= 15age old
Age maximum	<= 64age 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 remission state 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.