Drug Information for GELNIQUE (oxybutynin chloride) 10% gel (Watson Pharmaceuticals, Inc.): CLINICAL STUDIES

Ads
  • 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*).
    ParameterGELNIQUE 1 gram(N=389)Placebo(N=400)
    Mean (SD)MedianMean (SD)Median
    *Last-Observation-Carried-Forward statistical imputation for missing data
    Daily Incontinence Episodes
    Baseline5.4 (3.26)4.75.4 (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
    Baseline12.4 (3.34)11.712.2 (3.32)11.3
    Change from baseline-2.7 (3.21)-2.7-2.0 (2.82)-1.7
    P-value vs. placebo0.0017
    Urinary Void Volume (mL)
    Baseline163.4 (65.85)160.1167.9 (68.40)160.6
    Change from Baseline21.0 (65.33)11.53.8 (53.79)0.0
    P-value vs. placebo0.0018
  • Drug Information Provided by National Library of Medicine (NLM).
Ads