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

February 4, 2014 updated by: Allergan
This study will evaluate the safety and efficacy of AGN-214868 in patients with idiopathic overactive bladder (IOAB) and urinary incontinence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline, Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

July 1, 2010

First Submitted That Met QC Criteria

July 2, 2010

First Posted (Estimate)

July 7, 2010

Study Record Updates

Last Update Posted (Estimate)

March 19, 2014

Last Update Submitted That Met QC Criteria

February 4, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 214868-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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