Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder - Full Text View

Sponsor:	Allergan
Information provided by (Responsible Party):	Allergan
ClinicalTrials.gov Identifier:	NCT00439140

Purpose

This study will assess the safety and efficacy of botulinum toxin Type A for the treatment of urinary incontinence overactive bladder in patients with a spinal cord injury or multiple sclerosis.

Condition	Intervention	Phase
Overactive Bladder	Biological: botulinum toxin Type A 200U Biological: botulinum toxin Type A 300U Biological: placebo; botulinum Toxin Type A 200U Biological: Placebo; botulinum toxin Type A 300U	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Botox Urinary Incontinence

Drug Information available for: Botulinum toxin A Clostridium botulinum toxin

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

Forced Vital Capacity [ Time Frame: Week 2 ] [ Designated as safety issue: Yes ]
Forced Expiratory Volume [ Time Frame: Week 2 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pulmonary function [ Time Frame: Weeks 2 - 52 ] [ Designated as safety issue: Yes ]
Number of episodes of urinary incontinence (urodynamics) [ Time Frame: Weeks 2 - 52 ] [ Designated as safety issue: No ]
Peak (amplitude) detrusor pressure (urodynamics) [ Time Frame: Weeks 2 - 52 ] [ Designated as safety issue: No ]
Maximum cystometric capacity (urodynamics) [ Time Frame: Weeks 2 - 52 ] [ Designated as safety issue: No ]

Estimated Enrollment:	135
Study Start Date:	June 2007
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 botulinum toxin Type A 200U	Biological: botulinum toxin Type A 200U botulinum toxin Type A 200 U injection on Day 1 followed by botulinum toxin Type A 200 U injection > 12 weeks Other Name: BOTOX®
Experimental: 2 botulinum toxin Type A 300U	Biological: botulinum toxin Type A 300U botulinum toxin Type A 300 U injection on Day 1 followed by botulinum toxin Type A 300 U injection > 12 weeks Other Name: BOTOX®
3 Placebo followed by botulinum toxin Type A 200U	Biological: placebo; botulinum Toxin Type A 200U Placebo injection on Day 1 followed by botulinum toxin Type A 200U injection > 12 weeks Other Name: saline
4 Placebo followed by botulinum toxin Type A 300U	Biological: Placebo; botulinum toxin Type A 300U Placebo injection on Day 1 followed by botulinum toxin Type A 300 U injection > 12 weeks Other Name: saline

Detailed Description:

Botulinum toxin Type A 300U has been discontinued from the study. Patients remaining in the study who were allocated to receive botulinum toxin Type A 300U at treatment 2 (and had not yet received it) will receive botulinum toxin Type A 200U instead.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Urinary incontinence as a result of neurogenic overactive bladder due to spinal cord injury or multiple sclerosis
Inadequate response to anticholinergic medication used to treat overactive bladder.
Neurological respiratory impairment and abnormal pulmonary function test results

Exclusion Criteria:

History or evidence of pelvic or urologic abnormality
Previous or current diagnosis of bladder or prostate cancer
Symptomatic or untreated urinary tract infection at time of enrollment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00439140

Contacts

Contact: Allergan Inc.

clinicaltrials@allergan.com

Locations

United States, Illinois
	Recruiting
Hines, Illinois, United States
Australia, Queensland
	Recruiting
Brisbane, Queensland, Australia
Canada, Alberta
	Withdrawn
Edmonton, Alberta, Canada
Canada, British Columbia
	Recruiting
Victoria, British Columbia, Canada
France
	Withdrawn
Nimes Cedex, France
India
	Recruiting
Bangalore, India
Netherlands
	Withdrawn
Amsterdam, Netherlands

Sponsors and Collaborators

Allergan

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Allergan
ClinicalTrials.gov Identifier:	NCT00439140 History of Changes
Other Study ID Numbers:	191622-082
Study First Received:	February 21, 2007
Last Updated:	December 13, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Botulinum Toxins, Type A
Botulinum Toxins
Trichostatin A
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Synthesis Inhibitors
Antifungal Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on February 09, 2012