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

Sponsored by:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00311376

Purpose

The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A in treating overactive bladder in spinal cord injury or multiple sclerosis patients.

Condition	Intervention	Phase
Overactive Bladder	Biological: botulinum toxin Type A Other: Placebo/Botulinum toxin Type A Other: Placebo/botulinum toxin Type A	Phase III

MedlinePlus related topics: Botox Urinary Incontinence

Drug Information available for: Clostridium botulinum toxin

U.S. FDA Resources

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

Further study details as provided by Allergan:

Primary Outcome Measures:

Number of Episodes of Urinary Incontinence [ Time Frame: Week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Maximum cystometric capacity (urodynamics) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
Peak (amplitude) detrusor pressure (urodynamics) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
Incontinence Quality of Life Instrument [ Time Frame: Weeks 6- 24 ] [ Designated as safety issue: No ]

Estimated Enrollment:	405
Study Start Date:	August 2006
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Biological: botulinum toxin Type A botulinum toxin Type A 200 U (tx 1) followed by botulinum toxin Type A 200 U (tx 2); injections into detrusor, at > 12 weeks interval
2: Experimental	Biological: botulinum toxin Type A botulinum toxin Type A 300 U (tx 1) followed by botulinum toxin Type A 300 U (tx 2); injections into detrusor, at > 12 weeks interval
3 placebo followed by experimental	Other: Placebo/Botulinum toxin Type A Placebo (tx 1) followed by botulinum toxin Type A 200 U (tx 2); injections into detrusor, at > 12 weeks interval
4 placebo followed by experimental	Other: Placebo/botulinum toxin Type A Placebo (tx 1) followed by botulinum toxin Type A 300 U (tx 2), injections into detrusor, at > 12 weeks interval

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00311376

Contacts

Contact: Allergan, Inc.

clinicaltrials@allergan.com

Locations

United States, Michigan
	Recruiting
Royal Oak, Michigan, United States

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

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:	191622-515
Study First Received:	April 4, 2006
Last Updated:	March 9, 2009
ClinicalTrials.gov Identifier:	NCT00311376 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Signs and Symptoms
Urinary Bladder, Overactive
Botulinum Toxins
Cystocele

Urologic Diseases
Urinary Bladder Diseases
Peripheral Nervous System Agents
Botulinum Toxin Type A

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 May 07, 2009