Status:
COMPLETED
Efficacy and Tolerability of DITROPAN XL (Oxybutynin Chloride) Versus DETROL LA (Tolterodine Tartrate) in Treatment of Overactive Bladder
Lead Sponsor:
Alza Corporation, DE, USA
Conditions:
Urinary Incontinence
Eligibility:
FEMALE
18-99 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the efficacy of DITROPAN® XL (oxybutynin chloride) Extended-Release Tablets and DETROL® LA (tolterodine tartrate extended-release capsules) in the reduction o...
Detailed Description
The objective of this study is to compare the efficacy and tolerability of DITROPAN® XL 10 mg once-daily and DETROL® LA 4 mg once-daily in the reduction of urge urinary incontinence episodes in female...
Eligibility Criteria
Inclusion
- Participants who are able to differentiate urinary incontinence episodes associated with urgency from urinary incontinence episodes not associated with urgency
- during the 7 day baseline period have 21 to 60 urge urinary incontinence (Urge-UI) episodes, a greater number of Urge-UI episodes than urinary incontinence not associated with urge, and an average of 10 or more voids per 24 hours
- are in good general health as determined by medical history, physical examination (general, genital, pelvic, and rectal), laboratory tests and urinalysis
- if taking antihypertension medication, must be on a stable dose
- and if of child-bearing potential, practicing an acceptable method of birth control, and must have a negative pregnancy test at Visit 2 and Visit 3
Exclusion
- Participants with known, treatable genitourinary conditions (identified on history or on examination) that may cause incontinence (e.g., urinary tract infection, interstitial cystitis, urinary tract obstruction, urethral diverticulum, bladder tumor, bladder stone)
- have given birth or have had pelvic, vaginal or bladder surgery less than 6 months before study enrollment
- with a second post-void residual urine volume \> 150 mL at the time of screening (determined by abdominal ultrasound)
- with significant medical problems or other organ abnormality that places them at risk from participating in the study or at a significant risk of developing complete urinary retention
- with significant impairment of the liver or kidneys as determined by laboratory assessments or hematuria (red blood cells in microscopic urinalysis)
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2002
Estimated Enrollment :
790 Patients enrolled
Trial Details
Trial ID
NCT00293839
End Date
December 1 2002
Last Update
February 3 2025
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