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

Urinary Bladder, Overactive Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01157377
• Other study ID #: 214868-004
• Status: Completed
• Phase: Phase 2
• First received: July 1, 2010
• Last updated: February 4, 2014
• Start date: October 2010
• Est. completion date: May 2013

Study information

• Verified date: February 2014
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: May 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Bladder, Overactive

Intervention

Drug:
• AGN-214868
AGN-214868 injected into the bladder.
• AGN-214868 placebo
AGN-214868 placebo injected into the bladder.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  France,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline, Week 12	No