Phase 2
Completed N=156
Safety and Efficacy Study of AGN-214868 in Patients With Idiopathic Overactive Bladder and Urinary Incontinence
Urinary Bladder, Overactive
Source: ClinicalTrials.gov NCT01157377 ↗
Enrolled (actual)
156
Serious AEs
7.0%
Results posted
Mar 2014
Primary outcomePrimary: Change From Baseline in the Daily Average Number of Micturition (Urination) Episodes — 13.7; 12.2; 11.0; 10.6 Episodes
Summary
This study will evaluate the safety and efficacy of AGN-214868 in patients with idiopathic overactive bladder (IOAB) and urinary incontinence.
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 | — |
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
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. Informational only — not medical advice.