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

Sponsor:	Allergan
Information provided by:	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 Biological: placebo/Botulinum Toxin Type A Biological: Placebo/botulinum toxin Type A	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Botox Urinary Incontinence

Drug Information available for: 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 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Biological: botulinum toxin Type A botulinum toxin Type A 200 U injection on Day 1 followed by botulinum toxin Type A 200 U injection > 12 weeks
2: Experimental	Biological: botulinum toxin Type A botulinum toxin Type A 300 U injection on Day 1 followed by botulinum toxin Type A 300 U injection > 12 weeks
3 Placebo followed by experimental	Biological: placebo/Botulinum Toxin Type A Placebo injection on Day 1 followed by Botox 200 U injection > 12 weeks
4 Placebo followed by experimental	Biological: Placebo/botulinum toxin Type A Placebo injection on Day 1 followed by botulinum toxin Type A 300 U injection > 12 weeks

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
	Recruiting
Edmonton, Alberta, Canada
France
	Recruiting
Nimes Cedex, France
India
	Recruiting
Bangalore, India
Netherlands
	Recruiting
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, Inc. ( Therapeutic Area Head )
Study ID Numbers:	191622-082
Study First Received:	February 21, 2007
Last Updated:	January 4, 2010
ClinicalTrials.gov Identifier:	NCT00439140 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Urinary Bladder, Overactive
Anti-Dyskinesia Agents
Urinary Bladder Diseases
Physiological Effects of Drugs
Neuromuscular Agents
Pharmacologic Actions
Urological Manifestations

Signs and Symptoms
Botulinum Toxins
Urologic Diseases
Therapeutic Uses
Peripheral Nervous System Agents
Botulinum Toxin Type A
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010