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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00284518




Registration number
NCT00284518
Ethics application status
Date submitted
31/01/2006
Date registered
1/02/2006
Date last updated
17/12/2012

Titles & IDs
Public title
Safety and Efficacy Study of Botulinum Toxin Type A to Treat Lower Urinary Symptoms Due to Benign Prostatic Hyperplasia
Scientific title
Secondary ID [1] 0 0
191622-517
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Benign Prostatic Hyperplasia 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - botulinum toxin Type A
Treatment: Drugs - normal saline

Experimental: botulinum toxin Type A 300 U - Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.

Experimental: botulinum toxin Type A 200 U - Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.

Experimental: botulinum toxin Type A 100 U - Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.

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


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

Treatment: Drugs: normal saline
Normal Saline (Placebo) transperineal or transrectal injection on Day 1.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in International Prostate Symptom Score (IPSS) at Week 12
Timepoint [1] 0 0
Baseline, Week 12
Secondary outcome [1] 0 0
Change From Baseline in International Prostate Symptom Score (IPSS) at Week 72
Timepoint [1] 0 0
Baseline, Week 72
Secondary outcome [2] 0 0
Change From Baseline in Peak Urine Flow Rate
Timepoint [2] 0 0
Baseline, Week 12, Week 72
Secondary outcome [3] 0 0
Change From Baseline in Total Prostate Volume
Timepoint [3] 0 0
Baseline, Week 12, Week 72
Secondary outcome [4] 0 0
Change From Baseline in Transitional Zone Prostate Volume
Timepoint [4] 0 0
Baseline, Week 12, Week 72
Secondary outcome [5] 0 0
Change From Baseline in Post-Void Residual
Timepoint [5] 0 0
Baseline, Week 2, Week 12, Week 72

Eligibility
Key inclusion criteria
* Lower urinary tract symptoms due to benign prostatic hyperplasia
* Enlarged prostate volume by rectal ultrasound
Minimum age
50 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2010
Sample size
Target
Accrual to date
Final
380
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Murdoch
Recruitment postcode(s) [1] 0 0
- Murdoch
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Vienna
Country [2] 0 0
Canada
State/province [2] 0 0
British Columbia
Country [3] 0 0
Czech Republic
State/province [3] 0 0
Olomouc
Country [4] 0 0
France
State/province [4] 0 0
Paris Cedex 13
Country [5] 0 0
Germany
State/province [5] 0 0
Braunschweig
Country [6] 0 0
Italy
State/province [6] 0 0
Perugia
Country [7] 0 0
Korea, Republic of
State/province [7] 0 0
Seoul
Country [8] 0 0
Slovakia
State/province [8] 0 0
Martin
Country [9] 0 0
Taiwan
State/province [9] 0 0
Taipei
Country [10] 0 0
United Kingdom
State/province [10] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Allergan
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00284518
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Allergan
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00284518