A Study Comparing the Efficacy and Safety of OROS® Oxybutynin to That of Ditropan® (Immediate-release Oxybutynin) for the Treatment of Patients With Urge or Mixed Urinary Incontinence.
Condition: Urge Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Urge
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the efficacy and safety of OROS® oxybutynin to that
      of Ditropan® (immediate-release oxybutynin) for the treatment of patients with urge or mixed
      urinary incontinence. Oxybutynin is an antispasmodic, anticholinergic medication for the
      treatment of the symptoms of overactive bladder.
    

Detailed description: 
      Ditropan® is indicated for the treatment of urge urinary incontinence, however patients tend
      to discontinue the medication or decrease the dose due to anticholinergic side effects. OROS®
      oxybutynin, a continuous release formulation, is expected to have fewer anticholinergic side
      effects than Ditropan® and may provide equal or better efficacy compared to Ditropan®. This
      is a randomized, multi-center, double-blind, parallel group, dose-escalation study comparing
      the efficacy and safety of OROS® oxybutynin to Ditropan® for the treatment of urge or mixed
      urinary incontinence at the minimum effective dose (MED), the maximum tolerated dose (MTD),
      or the maximum allowable dose (MAD) permitted under this protocol. Patients in both treatment
      groups begin study drug treatment at an oxybutynin dose of 5 mg per day. The dose is changed
      in 5 mg increments at 4- to 7-day intervals, depending on the safety and efficacy of the
      current dose. The maximum allowable dose for Ditropan® is 20 mg per day, which is the maximum
      daily adult dose specified in its labeling. Because controlled delivery of oxybutynin by an
      OROS® dosage form could potentially reduce side effects, it is believed that the drug could
      possibly be tolerated at doses higher than 20 mg per day. Consequently, the maximum allowable
      dose for OROS® oxybutynin is 30 mg per day, administered as a single daily dose. The primary
      measures of effectiveness include the change from baseline in the following assessments: the
      number of urge urinary incontinence episodes per week, the total number of urinary
      incontinence episodes, and total void frequency (normal and incontinent). Safety evaluations
      include the incidence of adverse events, physical examination and medical history, clinical
      laboratory tests, urinalysis, electrocardiograms (ECGs), vital signs, and the Anticholinergic
      Effects Assessment (ACEA) questionnaire.

      OROS® (oxybutynin chloride) 5 mg tablets, one to six tablets per day (5 mg/day to 30 mg/day)
      as a single morning oral dose for 11 days up to 70 days, and Ditropan (oxybutynin chloride) 5
      mg tablets, one to four tablets per day orally (5 mg per day to 5 mg four times per day) for
      10 daysup to 61 days.
    

Intervention name(s): OROS® oxybutynin or Ditropan®
Intervention type(s): Drug
Intervention MeSH terms: Oxybutynin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Ditropan®; OROS®; urge; oxybutynin; mixed urinary incontinence