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

Primary Purpose

Urinary Bladder, Overactive

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AGN-214868
AGN-214868 placebo
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Bladder, Overactive

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

AGN-214868 total dose 500 ng

AGN-214868 total dose 1000 ng

AGN-214868 total dose 2000 ng

AGN-214868 total dose 6000 ng

AGN-214868 total dose 18000 ng

AGN-214868 total dose 60000 ng

Placebo to AGN-214868

Arm Description

AGN-214868 injected into the bladder for total dose of 500 ng on Day 1.

AGN-214868 injected into the bladder for total dose of 1000 ng on Day 1.

AGN-214868 injected into the bladder for total dose of 2000 ng on Day 1.

AGN-214868 injected into the bladder for total dose of 6000 ng on Day 1.

AGN-214868 injected into the bladder for total dose of 18000 ng on Day 1.

AGN-214868 injected into the bladder for total dose of 60000 ng on Day 1.

Placebo to AGN-214868 injected into the bladder on Day 1.

Outcomes

Primary Outcome Measures

Change From Baseline in the Daily Average Number of Micturition (Urination) Episodes
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).

Secondary Outcome Measures

Full Information

First Posted
July 1, 2010
Last Updated
February 4, 2014
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT01157377
Brief Title
Safety and Efficacy Study of AGN-214868 in Patients With Idiopathic Overactive Bladder and Urinary Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder, Overactive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AGN-214868 total dose 500 ng
Arm Type
Experimental
Arm Description
AGN-214868 injected into the bladder for total dose of 500 ng on Day 1.
Arm Title
AGN-214868 total dose 1000 ng
Arm Type
Experimental
Arm Description
AGN-214868 injected into the bladder for total dose of 1000 ng on Day 1.
Arm Title
AGN-214868 total dose 2000 ng
Arm Type
Experimental
Arm Description
AGN-214868 injected into the bladder for total dose of 2000 ng on Day 1.
Arm Title
AGN-214868 total dose 6000 ng
Arm Type
Experimental
Arm Description
AGN-214868 injected into the bladder for total dose of 6000 ng on Day 1.
Arm Title
AGN-214868 total dose 18000 ng
Arm Type
Experimental
Arm Description
AGN-214868 injected into the bladder for total dose of 18000 ng on Day 1.
Arm Title
AGN-214868 total dose 60000 ng
Arm Type
Experimental
Arm Description
AGN-214868 injected into the bladder for total dose of 60000 ng on Day 1.
Arm Title
Placebo to AGN-214868
Arm Type
Placebo Comparator
Arm Description
Placebo to AGN-214868 injected into the bladder on Day 1.
Intervention Type
Drug
Intervention Name(s)
AGN-214868
Intervention Description
AGN-214868 injected into the bladder.
Intervention Type
Drug
Intervention Name(s)
AGN-214868 placebo
Intervention Description
AGN-214868 placebo injected into the bladder.
Primary Outcome Measure Information:
Title
Change From Baseline in the Daily Average Number of Micturition (Urination) Episodes
Description
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).
Time Frame
Baseline, Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Richmond
State/Province
Virginia
Country
United States
City
Lyon
Country
France
City
Amsterdam
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

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

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