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

Sponsor:	Allergan
Information provided by (Responsible Party):	Allergan
ClinicalTrials.gov Identifier:	NCT01157377

Purpose

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

Condition	Intervention	Phase
Urinary Bladder, Overactive	Drug: AGN-214868 Drug: AGN-214868 placebo	Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Urinary Incontinence Urine and Urination

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

Change from baseline in number of micturition (urination) episodes at week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Scores on the International Consultation on Incontinence Questionnaire-Overactive Bladder (ICIQ-OAB) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment:	132
Study Start Date:	October 2010
Estimated Study Completion Date:	January 2013
Estimated Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 AGN-214868 total dose 500ng	Drug: AGN-214868 AGN-214868 injected into the bladder for total dose of 500ng
Experimental: 2 AGN-214868 total dose 1000ng	Drug: AGN-214868 AGN-214868 injected into the bladder for total dose of 1000ng
Experimental: 3 AGN-214868 total dose 2000ng	Drug: AGN-214868 AGN-214868 injected into the bladder for total dose of 2000ng
Placebo Comparator: 6 AGN-214868 placebo	Drug: AGN-214868 placebo AGN-214868 placebo injected into the bladder
Experimental: 4 AGN-214868 total dose 6000ng	Drug: AGN-214868 AGN-214868 injected into the bladder for total dose of 6000ng
Experimental: 5 AGN-214868 total dose 18000ng	Drug: AGN-214868 AGN-214868 injected into the bladder for total dose of 18000ng

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01157377

Contacts

Contact: Allergan Inc.

Locations

United States, Virginia
	Recruiting
Richmond, Virginia, United States
France
	Recruiting
Lyon, France
Netherlands
	Recruiting
Amsterdam, Netherlands

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

Additional Information:

More Information This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Allergan
ClinicalTrials.gov Identifier:	NCT01157377 History of Changes
Other Study ID Numbers:	214868-004
Study First Received:	July 1, 2010
Last Updated:	April 20, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Urinary Incontinence
Urinary Bladder, Overactive
Urination Disorders
Urologic Diseases

Urological Manifestations
Signs and Symptoms
Urinary Bladder Diseases

ClinicalTrials.gov processed this record on May 23, 2012