Status:
COMPLETED
An Efficacy and Safety Study of Oxybutynin Chloride Oral Osmotic Therapeutic System (OROS) in Korean Overactive Bladder Participants
Lead Sponsor:
Janssen Korea, Ltd., Korea
Conditions:
Urinary Bladder, Overactive
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The objective of this study is to evaluate the efficacy of oxybutynin chloride oral osmotic therapeutic system (OROS) on patient-reported outcomes after 12 weeks of treatment by dose escalation in par...
Detailed Description
This is a multicenter (when more than one hospital or medical school team work on a medical research study), open-label (all people know the identity of the intervention), prospective (study following...
Eligibility Criteria
Inclusion
- Participants who fulfilled all of the following criteria in their micturition charts completed for 3 days prior to visit 2 (Baseline): mean voiding frequency greater than or equal to 8 times per 24 hours and mean frequency of urinary urgency greater than or equal to 2 times per 24 hours (urgency means sudden and strong urge to urinate and a urinary sensation scale score greater than or equal to 3 in the micturition chart)
- Participants with overactive bladder symptoms lasting for 3 months or longer prior to study initiation
- Participants who were capable of completing micturition chart and survey questionnaires and provided informed consent to complete them
- Participants who could sign on the informed consent form after fully listening to and understanding about characteristics, risks and benefits of the study
Exclusion
- Participants with stress urinary incontinence (not able to control bladder actions) or participants with complicated incontinence dominantly presenting stress urinary incontinence when judging based on medical history
- Participants with a hepatic (pertaining to liver) or renal (pertaining to kidneys) disease indicating serum aspartate transaminase (AST \[SGOT\]), alanine transaminase (ALT \[SGPT\]), alkaline phosphatase or creatinnine concentration twice or more of normal upper limit
- Participants contraindicated to use anticholinergics including uncontrolled narrow angle glaucoma (increased pressure inside the eye that causes visual problems), urinary retention or gastrointestinal tract retention
- Participants experiencing a symptom of acute urinary tract infection (UTI) during the run-in period
- Participants with recurrent UTI who had medical history of treatment for UTI symptom 5 times or more in the past one year
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
345 Patients enrolled
Trial Details
Trial ID
NCT00613327
Start Date
September 1 2007
End Date
June 1 2008
Last Update
November 19 2013
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