A Comparison of a New Drug to Treat Overactive Bladder vs. Placebo

Watson Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Overactive Bladder

Treatments: Drug: Oxybutynin topical gel; Other: Placebo topical gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00350636

OG05009

Details and patient eligibility

About

A new drug for overactive bladder is compared to placebo to determine if it is safe and effective. The study lasts approximately 12 weeks.

Enrollment: 789 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Females and males, 18 years of older with overactive bladder symptoms

Exclusion criteria

• Treatable conditions that may cause urinary incontinence
• Medical conditions in which it would be unsafe to use an anti-cholinergic agent.
• The use of concomitant drugs that would confound the efficacy evaluation.
• The use of concomitant drugs that would be unsafe with an anti-cholinergic agent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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789 participants in 2 patient groups, including a placebo group

Oxybutynin topical gel

Experimental group

Description:

Oxybutynin topical gel

Treatment:

Drug: Oxybutynin topical gel

Placebo topical gel

Placebo Comparator group

Description:

placebo topical gel

Treatment:

Other: Placebo topical gel