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

This study is ongoing, but not recruiting participants.

First Received on April 16, 2010. Last Updated on April 10, 2012 History of Changes

Sponsor:	Allergan
Information provided by (Responsible Party):	Allergan
ClinicalTrials.gov Identifier:	NCT01107392

Purpose

This study will evaluate the safety and efficacy of intraprostatic administration of botulinum toxin type A (BOTOX®) compared with placebo to treat urinary tract symptoms due to benign prostatic hyperplasia.

Condition	Intervention	Phase
Benign Prostatic Hyperplasia	Drug: botulinum toxin type A Drug: Placebo (saline)	Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Botox

Drug Information available for: Onaclostox

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

Severity of Benign Prostatic Hyperplasia (BPH) symptoms as measured by the International Prostate Symptom Score questionnaire [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Peak Urinary Flow Rate [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Enrollment:	315
Study Start Date:	August 2010
Estimated Study Completion Date:	June 2012
Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: botulinum toxin type A botulinum toxin type A	Drug: botulinum toxin type A botulinum toxin type A total dose of 200 U equally divided and administered to each lateral prostatic lobe Other Name: BOTOX®
Placebo Comparator: Placebo (Saline) Placebo (Saline)	Drug: Placebo (saline) Placebo (saline) equally divided and administered to each lateral prostatic lobe

Eligibility

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical enlargement of the prostate gland
Body weight ≥ 50 kg or 110 lbs

Exclusion Criteria:

History of chronic prostatitis
History of two or more urinary tract infections in the past year or one in the last 6 months
History of bladder stones
History of previous prostate surgery
History of bladder cancer or prostate cancer
Any previous or current usage of botulinum toxin therapy of any serotype for any urological condition
Botulinum toxin therapy of any serotype for any non-urological condition or usage (e.g., cosmetic) during the previous 12 weeks prior to study entry

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01107392

Locations

United States, California

Newport Beach, California, United States
Canada, British Columbia

Surrey, British Columbia, Canada
Czech Republic

Praha, Czech Republic
France

Paris, France
Germany

Munich, Germany
Korea, Republic of

Seoul, Korea, Republic of
Philippines

Manila, Philippines
Poland

Poznan, Poland

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

No publications provided

Responsible Party:	Allergan
ClinicalTrials.gov Identifier:	NCT01107392 History of Changes
Other Study ID Numbers:	191622-100
Study First Received:	April 16, 2010
Last Updated:	April 10, 2012
Health Authority:	United States: Food and Drug Administration

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 May 23, 2012