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

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

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Key information

Conditions

Urinary Bladder, Overactive Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Lyon, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AGN-214868

Drug

AGN-214868 injected into the bladder.

AGN-214868 placebo

Drug

AGN-214868 placebo injected into the bladder.

Primary outcomes

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

Time frame: Baseline, Week 12

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).

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start: 2010
Primary completion: 2013
Study completion: 2013
First posted: Jul 7, 2010
Registry last updated: Mar 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed