NCT00910520

Brief Summary

The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A (onabotulinumtoxinA) in treating patients with idiopathic overactive bladder with urinary incontinence.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
548

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2009

Geographic Reach
7 countries

7 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

May 28, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 1, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

March 5, 2013

Completed
Last Updated

March 5, 2013

Status Verified

January 1, 2013

Enrollment Period

1.9 years

First QC Date

May 28, 2009

Results QC Date

January 29, 2013

Last Update Submit

January 29, 2013

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Number of Daily Episodes of Urinary Incontinence

    A urinary incontinence episode is defined as an incident of involuntary loss of urine as recorded in a patient bladder diary during the 3 days before the Baseline and Week 12 study visits. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).

    Baseline, Week 12

Secondary Outcomes (2)

  • Change From Baseline in Number of Daily Micturition Episodes

    Baseline, Week 12

  • Change From Baseline in Volume Voided Per Micturition

    Baseline, Week 12

Study Arms (2)

onabotulinumtoxinA

EXPERIMENTAL

OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).

Biological: onabotulinumtoxinA

placebo/onabotulinumtoxinA

OTHER

Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).

Biological: onabotulinumtoxinADrug: normal saline

Interventions

onabotulinumtoxinABIOLOGICAL

OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable). Or, if placebo is administered at Day 1, onabotulinumtoxinA 100 U injected after a minimum of 12 weeks (if applicable).

Also known as: BOTOX®, botulinum toxin Type A
onabotulinumtoxinAplacebo/onabotulinumtoxinA
normal salineDRUG

Normal saline (placebo) injected into the detrusor at Day 1.

placebo/onabotulinumtoxinA

Eligibility Criteria

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

You may qualify if:

  • Symptoms of OAB (frequency/urgency) with urinary incontinence for at least 6 months
  • Inadequate response or limiting side effects with anticholinergics for the treatment of OAB

You may not qualify if:

  • Overactive Bladder caused by neurological condition
  • Patient has predominance of stress incontinence
  • History or evidence of pelvic or urological abnormality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Unknown Facility

Laguna Hills, California, United States

Location

Unknown Facility

Ghent, Belgium

Location

Unknown Facility

Prague, Czechia

Location

Unknown Facility

Tübingen, Germany

Location

Unknown Facility

Warsaw, Poland

Location

Unknown Facility

Moscow, Russia

Location

Unknown Facility

London, United Kingdom

Location

Related Publications (3)

  • Castejon N, Khalaf K, Ni Q, Cuervo J, Patrick DL. Psychometric properties of the incontinence utility index among patients with idiopathic overactive bladder: data from two multicenter, double-blind, randomized, Phase 3, placebo-controlled clinical trials. Health Qual Life Outcomes. 2015 Aug 1;13:116. doi: 10.1186/s12955-015-0306-5.

    PMID: 26231052DERIVED

  • Sievert KD, Chapple C, Herschorn S, Joshi M, Zhou J, Nardo C, Nitti VW. OnabotulinumtoxinA 100U provides significant improvements in overactive bladder symptoms in patients with urinary incontinence regardless of the number of anticholinergic therapies used or reason for inadequate management of overactive bladder. Int J Clin Pract. 2014 Oct;68(10):1246-56. doi: 10.1111/ijcp.12443. Epub 2014 Apr 22.

    PMID: 24754838DERIVED

  • Chapple C, Sievert KD, MacDiarmid S, Khullar V, Radziszewski P, Nardo C, Thompson C, Zhou J, Haag-Molkenteller C. OnabotulinumtoxinA 100 U significantly improves all idiopathic overactive bladder symptoms and quality of life in patients with overactive bladder and urinary incontinence: a randomised, double-blind, placebo-controlled trial. Eur Urol. 2013 Aug;64(2):249-56. doi: 10.1016/j.eururo.2013.04.001. Epub 2013 Apr 10.

    PMID: 23608668DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Botulinum Toxins, Type ASaline Solution

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

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological FactorsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Results Point of Contact

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

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 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2009

First Posted

June 1, 2009

Study Start

September 1, 2009

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

March 5, 2013

Results First Posted

March 5, 2013

Record last verified: 2013-01

Locations

US(1)DE(1)GB(1)CZ(1)BE(1)PL(1)RU(1)