Phase 2 N=156 Randomized Double-blind Treatment

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

Urinary Bladder, Overactive

Bottom Line

View on ClinicalTrials.gov: NCT01157377 ↗

Enrolled (actual)

156

Serious AEs

7.0%

Results posted

Mar 2014

Primary outcome: Primary: Change From Baseline in the Daily Average Number of Micturition (Urination) Episodes — 13.7; 12.2; 11.0; 10.6 Episodes

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: AGN-214868 (Drug); AGN-214868 placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Allergan
Primary completion: Feb 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in the Daily Average Number of Micturition (Urination) Episodes	13.7; 12.2; 11.0; 10.6; 11.7; 11.6	—

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01157377). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.