Safety and Efficacy Study of Botulinum Toxin Type A to Treat Lower Urinary Symptoms Due to Benign Prostatic Hyperplasia

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2010 by Allergan. Recruitment status was Active, not recruiting

First Received on January 31, 2006. Last Updated on February 3, 2010 History of Changes

Sponsor:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00284518

Purpose

The purpose of this study is to determine the safety and effectiveness of different doses of botulinum toxin Type A in treating lower urinary tract symptoms due to benign prostatic hyperplasia

Condition	Intervention	Phase
Benign Prostatic Hyperplasia	Biological: botulinum toxin Type A Biological: Placebo	Phase II

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 Urine and Urination

Drug Information available for: Botulinum toxin A Clostridium botulinum toxin

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

Change from baseline in International Prostate Symptom Score [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in peak urine flow rate [ Time Frame: Week 2 - 72 ] [ Designated as safety issue: No ]
Change from baseline in Post Void Residual [ Time Frame: Week 2 - 72 ] [ Designated as safety issue: No ]
Change from baseline in Sexual Function questionnaire [ Time Frame: Week 2 - 72 ] [ Designated as safety issue: No ]

Enrollment:	374
Study Start Date:	December 2005
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Biological: botulinum toxin Type A botulinum toxin Type A 300 U transrectal injection on Day 1 Other Name: BOTOX®
Experimental: 2	Biological: botulinum toxin Type A botulinum toxin Type A 200 U by transrectal injection at Day 1 Other Name: BOTOX®
Experimental: 3	Biological: botulinum toxin Type A botulinum toxin Type A 100 U by transrectal injection on Day 1 Other Name: BOTOX®
Placebo Comparator: 4	Biological: Placebo Placebo by transrectal injection on Day 1 Other Name: saline

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Lower urinary tract symptoms due to benign prostatic hyperplasia
Enlarged prostate volume by rectal ultrasound

Exclusion Criteria:

Previous prostate surgery
Previous or current diagnosis of prostate cancer
Use of other medications for the treatment of prostatic hyperplasia
Urinary tract infection

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00284518

Locations

Australia

Murdoch, Australia
Austria

Vienna, Austria
Canada, British Columbia

Victoria, British Columbia, Canada
Czech Republic

Olomouc, Czech Republic
France

Paris Cedex 13, France
Germany

Braunschweig, Germany
Italy

Perugia, Italy
Korea, Republic of

Seoul, Korea, Republic of
Slovakia

Martin, Slovakia
Taiwan

Taipei, Taiwan
United Kingdom

London, United Kingdom

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:	Therapeutic Area Head, Allergan, Inc.
ClinicalTrials.gov Identifier:	NCT00284518 History of Changes
Other Study ID Numbers:	191622-517
Study First Received:	January 31, 2006
Last Updated:	February 3, 2010
Health Authority:	Canada: Health Canada

Additional relevant MeSH terms:

Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Botulinum Toxins, Type A
Botulinum Toxins

Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012