Status:

COMPLETED

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

Lead Sponsor:

Allergan

Conditions:

Urinary Bladder, Overactive

Eligibility:

All Genders

18-75 years

Phase:

PHASE2

Brief Summary

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

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

October 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2013

Estimated Enrollment :

160 Patients enrolled

Trial Details

Trial ID

NCT01157377

Start Date

October 1 2010

End Date

May 1 2013

Last Update

March 19 2014

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Richmond, Virginia, United States

2

Lyon, France

3

Amsterdam, Netherlands