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Botulinum Toxin Type A for LUTS due to BPH
NCT00284518Phase 2
Key facts
- Status
- Completed
- Start
- Dec 2005
- Primary completion
- May 2009
- Countries
- 11
- Sponsor
- Allergan
- Modality
- Recombinant Proteins and Enzymes
- Drugs
- onabotulinumtoxinA
- Conditions
- benign prostatic hyperplasia (BPH)
01
Overview
Phase 2, randomised, double-blind trial of onabotulinumtoxinA in benign prostatic hyperplasia (BPH) (4 arms), sponsored by Allergan. Primary endpoint: International Prostate Symptom Score at 12 weeks. Started Dec 2005; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
Botox 300 U
Botulinum toxin Type A 300 U injection
Botox 200 U
Botulinum toxin Type A 200 U injection
Botox 100 U
Botulinum toxin Type A 100 U injection
Placebo
Normal Saline injection
03
Who it enrols
Men with lower urinary tract symptoms due to benign prostatic hyperplasia and enlarged prostate volume. Patients with previous prostate surgery, prostate cancer, or urinary tract infection are excluded.
04
Endpoints
Primary
International Prostate Symptom Score
Secondary
International Prostate Symptom Score
Peak Urine Flow Rate
Total Prostate Volume
Transitional Zone Prostate Volume
Post-Void Residual
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