NCT01157377

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2010

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 7, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
11 months until next milestone

Results Posted

Study results publicly available

March 19, 2014

Completed
Last Updated

March 19, 2014

Status Verified

February 1, 2014

Enrollment Period

2.3 years

First QC Date

July 1, 2010

Results QC Date

February 4, 2014

Last Update Submit

February 4, 2014

Conditions

Urinary Bladder, Overactive

Outcome Measures

Primary Outcomes (1)

  • 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).

    Baseline, Week 12

Study Arms (7)

AGN-214868 total dose 500 ng

EXPERIMENTAL

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

Drug: AGN-214868

AGN-214868 total dose 1000 ng

EXPERIMENTAL

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

Drug: AGN-214868

AGN-214868 total dose 2000 ng

EXPERIMENTAL

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

Drug: AGN-214868

AGN-214868 total dose 6000 ng

EXPERIMENTAL

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

Drug: AGN-214868

AGN-214868 total dose 18000 ng

EXPERIMENTAL

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

Drug: AGN-214868

AGN-214868 total dose 60000 ng

EXPERIMENTAL

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

Drug: AGN-214868

Placebo to AGN-214868

PLACEBO COMPARATOR

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

Drug: AGN-214868 placebo

Interventions

AGN-214868DRUG

AGN-214868 injected into the bladder.

AGN-214868 total dose 1000 ngAGN-214868 total dose 18000 ngAGN-214868 total dose 2000 ngAGN-214868 total dose 500 ngAGN-214868 total dose 6000 ngAGN-214868 total dose 60000 ng
AGN-214868 placeboDRUG

AGN-214868 placebo injected into the bladder.

Placebo to AGN-214868

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Richmond, Virginia, United States

Location

Unknown Facility

Lyon, France

Location

Unknown Facility

Amsterdam, Netherlands

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Therapeutic Area Head,
Organization
Allergan, Inc
clinicaltrials@allergan.com
714-246-4500

Study Officials

  • Medical Director

    Allergan

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2010

First Posted

July 7, 2010

Study Start

October 1, 2010

Primary Completion

February 1, 2013

Study Completion

May 1, 2013

Last Updated

March 19, 2014

Results First Posted

March 19, 2014

Record last verified: 2014-02

Locations

FR(1)NL(1)US(1)