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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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00284518