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

NCT ID: NCT00284518

Last Updated: 2012-12-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

380 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2010-05-31

Brief Summary

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The purpose of this study was 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.

Detailed Description

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Conditions

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Benign Prostatic Hyperplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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botulinum toxin Type A 300 U

Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.

Group Type EXPERIMENTAL

botulinum toxin Type A

Intervention Type BIOLOGICAL

Botulinum toxin Type A 300 U, 200 U or 100 U transperineal or transrectal injection on Day 1.

botulinum toxin Type A 200 U

Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.

Group Type EXPERIMENTAL

botulinum toxin Type A

Intervention Type BIOLOGICAL

Botulinum toxin Type A 300 U, 200 U or 100 U transperineal or transrectal injection on Day 1.

botulinum toxin Type A 100 U

Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.

Group Type EXPERIMENTAL

botulinum toxin Type A

Intervention Type BIOLOGICAL

Botulinum toxin Type A 300 U, 200 U or 100 U transperineal or transrectal injection on Day 1.

Placebo (Normal Saline)

Placebo (Normal Saline) transperineal or transrectal injection on Day 1.

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type DRUG

Normal Saline (Placebo) transperineal or transrectal injection on Day 1.

Interventions

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botulinum toxin Type A

Botulinum toxin Type A 300 U, 200 U or 100 U transperineal or transrectal injection on Day 1.

Intervention Type BIOLOGICAL

normal saline

Normal Saline (Placebo) transperineal or transrectal injection on Day 1.

Intervention Type DRUG

Other Intervention Names

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BOTOX®

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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Murdoch, , Australia

Site Status

Vienna, , Austria

Site Status

Victoria, British Columbia, Canada

Site Status

Olomouc, , Czechia

Site Status

Paris, , France

Site Status

Braunschweig, , Germany

Site Status

Perugia, , Italy

Site Status

Martin, , Slovakia

Site Status

Seoul, , South Korea

Site Status

Taipei, , Taiwan

Site Status

London, , United Kingdom

Site Status

Countries

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Australia Austria Canada Czechia France Germany Italy Slovakia South Korea Taiwan United Kingdom

References

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Marberger M, Chartier-Kastler E, Egerdie B, Lee KS, Grosse J, Bugarin D, Zhou J, Patel A, Haag-Molkenteller C. A randomized double-blind placebo-controlled phase 2 dose-ranging study of onabotulinumtoxinA in men with benign prostatic hyperplasia. Eur Urol. 2013 Mar;63(3):496-503. doi: 10.1016/j.eururo.2012.10.005. Epub 2012 Oct 12.

Reference Type DERIVED
PMID: 23098762 (View on PubMed)

Other Identifiers

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191622-517

Identifier Type: -

Identifier Source: org_study_id