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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01157377
• Date of registration: 01/07/2010
• Prospective Registration: Yes
• Primary sponsor: Allergan
• Public title: Safety and Efficacy Study of AGN-214868 in Patients With Idiopathic Overactive Bladder and Urinary Incontinence
• Date of first enrolment: October 2010
• Target sample size: 160
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01157377
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

France, Netherlands, United States

Contacts

• Name: Medical Director
• Affiliation: Allergan

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Urinary Bladder, Overactive

Intervention(s)

Drug: AGN-214868

Drug: AGN-214868 placebo

Primary Outcome(s)

Change From Baseline in the Daily Average Number of Micturition (Urination) Episodes [Time Frame: Baseline, Week 12]

Secondary ID(s)

214868-004

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 19/03/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01157377