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Drug Information for GELNIQUE (oxybutynin chloride) 10% gel (Watson Pharmaceuticals, Inc.): CLINICAL STUDIES
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The efficacy and safety of GELNIQUE were evaluated in a single randomized, double-blind, placebo-controlled, parallel group 12-week study for the treatment of overactive bladder with symptoms of urge incontinence, urgency and frequency. Key entry criteria included adults with symptomatic overactive bladder with an average of ≥ 4 incontinence episodes in a 3-day period and at least 8 micturitions per day. Patients were randomized to daily applications of GELNIQUE 1 gram or matching placebo gel. A total of 389 patients received GELNIQUE and 400 patients received placebo gel. The majority of patients were Caucasian (86.3%) and female (89.2%), with a mean age of 59.4 years (range: 18 to 88 years). The average duration of urinary incontinence was approximately 8.5 years and approximately 75% of patients had no prior pharmacological treatment for urinary incontinence.
Patients treated with GELNIQUE experienced a statistically significant decrease in the number of urinary incontinence episodes per day from baseline to endpoint (the primary efficacy endpoint) compared with placebo (p<0.0001) as well as a decrease in the average daily urinary frequency (p=0.0017) and an increase in the average urine volume per void (p=0.0018).
Mean and median change from baseline in daily incontinence episodes (primary endpoint), urinary frequency, and urinary void volume (secondary endpoints) between placebo and GELNIQUE are summarized in Table 3.
Table 3: Mean and median change from baseline for incontinence episodes, urinary frequency, and urinary void volume at Week 12 (LOCF*). Parameter GELNIQUE 1 gram(N=389) Placebo(N=400) Mean (SD) Median Mean (SD) Median *Last-Observation-Carried-Forward statistical imputation for missing data Daily Incontinence Episodes Baseline 5.4 (3.26) 4.7 5.4 (3.28) 4.7 Change from baseline -3.0 (2.73) -2.7 -2.5 (3.06) -2.0 Mean difference [GELNIQUE – placebo] (95% CI) -0.5 (-0.14, -0.87) P-value vs. placebo <0.0001 Daily Urinary Frequency Baseline 12.4 (3.34) 11.7 12.2 (3.32) 11.3 Change from baseline -2.7 (3.21) -2.7 -2.0 (2.82) -1.7 P-value vs. placebo 0.0017 Urinary Void Volume (mL) Baseline 163.4 (65.85) 160.1 167.9 (68.40) 160.6 Change from Baseline 21.0 (65.33) 11.5 3.8 (53.79) 0.0 P-value vs. placebo 0.0018
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