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

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ClinicalTrials.gov Identifier: NCT01157377
Recruitment Status : Completed
First Posted : July 7, 2010
Results First Posted : March 19, 2014
Last Update Posted : March 19, 2014
Sponsor:
Information provided by (Responsible Party):
Allergan

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

Condition or disease Intervention/treatment Phase
Urinary Bladder, Overactive Drug: AGN-214868 Drug: AGN-214868 placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : October 2010
Actual Primary Completion Date : February 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: AGN-214868 total dose 500 ng
AGN-214868 injected into the bladder for total dose of 500 ng on Day 1.
Drug: AGN-214868
AGN-214868 injected into the bladder.
Experimental: AGN-214868 total dose 1000 ng
AGN-214868 injected into the bladder for total dose of 1000 ng on Day 1.
Drug: AGN-214868
AGN-214868 injected into the bladder.
Experimental: AGN-214868 total dose 2000 ng
AGN-214868 injected into the bladder for total dose of 2000 ng on Day 1.
Drug: AGN-214868
AGN-214868 injected into the bladder.
Experimental: AGN-214868 total dose 6000 ng
AGN-214868 injected into the bladder for total dose of 6000 ng on Day 1.
Drug: AGN-214868
AGN-214868 injected into the bladder.
Experimental: AGN-214868 total dose 18000 ng
AGN-214868 injected into the bladder for total dose of 18000 ng on Day 1.
Drug: AGN-214868
AGN-214868 injected into the bladder.
Experimental: AGN-214868 total dose 60000 ng
AGN-214868 injected into the bladder for total dose of 60000 ng on Day 1.
Drug: AGN-214868
AGN-214868 injected into the bladder.
Placebo Comparator: Placebo to AGN-214868
Placebo to AGN-214868 injected into the bladder on Day 1.
Drug: AGN-214868 placebo
AGN-214868 placebo injected into the bladder.



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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01157377


Locations
United States, Virginia
Richmond, Virginia, United States
France
Lyon, France
Netherlands
Amsterdam, Netherlands
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01157377     History of Changes
Other Study ID Numbers: 214868-004
First Posted: July 7, 2010    Key Record Dates
Results First Posted: March 19, 2014
Last Update Posted: March 19, 2014
Last Verified: February 2014

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms