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

Phase 2

Completed

• Conditions: Urinary Bladder, Overactive
• Interventions: Drug: AGN-214868; Drug: AGN-214868 placebo

• Registration Number: NCT01157377
• Lead Sponsor: Allergan

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-01
• Study First Submitted QC: 2010-07-02
• Study First Posted: 2010-07-07
• Study Start: 2010-10
• Primary Completion: 2013-02
• Study Completion: 2013-05
• Status Verified: 2014-02
• Results First Submitted: 2014-02-04
• Results First Submitted QC: 2014-02-04
• Last Update Submitted: 2014-02-04
• Results First Posted: 2014-03-19
• Last Update Posted: 2014-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AGN-214868 total dose 60000 ng	AGN-214868	AGN-214868 injected into the bladder for total dose of 60000 ng on Day 1.
Placebo to AGN-214868	AGN-214868 placebo	Placebo to AGN-214868 injected into the bladder on Day 1.
AGN-214868 total dose 500 ng	AGN-214868	AGN-214868 injected into the bladder for total dose of 500 ng on Day 1.
AGN-214868 total dose 1000 ng	AGN-214868	AGN-214868 injected into the bladder for total dose of 1000 ng on Day 1.
AGN-214868 total dose 2000 ng	AGN-214868	AGN-214868 injected into the bladder for total dose of 2000 ng on Day 1.
AGN-214868 total dose 6000 ng	AGN-214868	AGN-214868 injected into the bladder for total dose of 6000 ng on Day 1.
AGN-214868 total dose 18000 ng	AGN-214868	AGN-214868 injected into the bladder for total dose of 18000 ng on Day 1.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in the Daily Average Number of Micturition (Urination) Episodes	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).