Safety and Efficacy Study of AGN-214868 in Patients With Idiopathic Overactive Bladder and Urinary Incontinence

Allergan160 enrolled

Overview

This study will evaluate the safety and efficacy of AGN-214868 in patients with idiopathic overactive bladder (IOAB) and urinary incontinence.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

160

Conditions

Urinary Bladder, Overactive

Interventions

AGN-214868DRUG

AGN-214868 injected into the bladder.

AGN-214868 placeboDRUG

AGN-214868 placebo injected into the bladder.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * If female, must be of nonreproductive potential * If male, must agree to use acceptable contraception * Symptoms of overactive bladder with urinary urgency incontinence * Inadequate response or limiting side effects with anticholinergics for the treatment of OAB Exclusion Criteria: * Overactive bladder caused by neurological condition (eg, spinal cord injury, multiple sclerosis) * History of bladder surgery * Treatment with botulinum toxin therapy of any serotype for any non-urological condition within the prior 12 weeks * Previous treatment with botulinum toxin therapy of any serotype for any urological condition

Locations (3)

Unnamed facility

Richmond, Virginia, United States

Unnamed facility

Lyon, France

Unnamed facility

Amsterdam, Netherlands

Outcomes

Primary Outcomes

Change From Baseline in the Daily Average Number of Micturition (Urination) Episodes

The average number of urinary episodes (urination into the toilet) was recorded by a patient bladder diary during 3 consecutive days in the week prior to Baseline and Week 12. A negative change from Baseline indicated improvement (fewer urinary episodes).

Time frame: Baseline, Week 12

Data from ClinicalTrials.gov

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