Efficacy and Safety of OROS Oybutynin and TTS Oxybutynin in Middle-Aged and Elderly Women With Urinary Incontinence
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|ClinicalTrials.gov Identifier: NCT00304499|
Recruitment Status : Completed
First Posted : March 20, 2006
Last Update Posted : May 19, 2011
|Condition or disease||Intervention/treatment||Phase|
|Urinary Incontinence||Drug: Oxybutynin||Phase 3|
Urinary incontinence (UI) refers to the involuntary loss of urine in sufficient amounts to be considered a social or health problem. While it is a psychologically distressing and socially disruptive, UI is believed to be an under reported and under diagnosed medical condition. This is a Multicenter, randomized, double-blind, placebo-controlled, parallel group study with 1 week of single-blinded placebo run-in. Patients will be randomized to 6 weeks double-blind treatment with oxybutynin or placebo. The primary hypothesis to be tested in this study is that the treatment difference in the change in incontinence episodes per week after 6 weeks of treatment in the double-blind phase between individual oxybutynin-treated group and combined placebo group is equal to zero.
The patients will receive oral OROS® containing oxybutynin, immediate release oral oxybutynin (1.7 or 2.5 mg) or TTS oxybutynin (60 cm2) daily for 7 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||176 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Efficacy and Safety of OROS® Oxybutynin and TTS Oxybutynin in Middle-Aged and Elderly Women With Urinary Incontinence|
|Study Start Date :||December 1995|
|Estimated Study Completion Date :||December 1996|
- The primary efficacy parameter is the mean change in urge incontinence episodes per week from baseline to last week after up to 6 weeks double-blind treatment.
- The secondary efficacy parameters are Mean incontinent episodes per week based on the Patient Urinary Diary (PUD); Mean diurnal and nocturnal micturition frequencies (PUD); Mean incontinence pads changed each day due to wetness (PUD).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00304499
|Study Director:||Alza Corporation Clinical Trial||Alza Corporation, DE, USA|