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2002 APR 18 - (NewsRx.com & NewsRx.net) -- Watson Pharmaceuticals, Inc., (WPI) announced positive preliminary results of a phase IIIb clinical study evaluating its transdermal oxybutynin product, the leading oral medication for overactive bladder, Detrol LA (tolterodine tartrate) and placebo.
The multicenter, placebo-controlled, double-blind, double-dummy clinical study involved 361 patients in 48 centers. Patients were randomized into 3 parallel treatment arms and treated for a period of 12 weeks with either 3.9mg/day transdermal oxybutynin twice weekly, oral 4mg Detrol LA daily, or placebo. All patients were required to have achieved a beneficial response to prior pharmacological treatment for overactive bladder for a minimum of 6 weeks to be eligible for the trial. Most patients had received either tolterodine or oxybutynin, with a median duration of greater than 1 year.
Preliminary results from this clinical study showed that patients treated with transdermal oxybutynin or Detrol LA experienced significant reductions in incontinent episodes as compared with placebo. Daily urinary incontinent episodes decreased by 42% in the placebo group as compared with 62% in the transdermal oxybutynin group and ...