NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Overactive bladder
Date of first enrollment	01/09/2010
Target sample size	320
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : SMP-986 INN of investigational material : Therapeutic category code : 251 Agents affecting urinary organs Dosage and Administration for Investigational material : Oral control material(s) Generic name etc : placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : Oral

Outcome(s)

Primary Outcome	Efficacy: Change from baseline in number of voids per day At 12 weeks
Secondary Outcome	Efficacy: Change from baseline in number of urgency episodes per day At 12 weeks

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	<= 80age old
Gender	Both
Include criteria	Patient with overactive bladder who meets the following criteria -Outpatient -Patient has overactive bladder syndrome over a successive period of at least 6 months prior to onset of the study -Patient can get to a bathroom without assistance and can record the bladder diary accurately
Exclude criteria	-Patient with bladder outlet obstruction -Patient has a neurological disease which has potential to cause overactive bladder syndrome -Patient has a polyuria