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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01157377
First received: July 1, 2010
Last updated: February 4, 2014
Last verified: February 2014
  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:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change From Baseline in the Daily Average Number of Micturition (Urination) Episodes [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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).


Enrollment: 160
Study Start Date: October 2010
Study Completion Date: May 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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
Results First Received: February 4, 2014
Last Updated: February 4, 2014
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 July 22, 2014