A New Drug for Benign Prostatic Hyperplasia (BPH) Compared With Placebo
Phase 3
Completed
- Conditions
- Benign Prostatic Hyperplasia (BPH)
- Interventions
- Other: Placebo
- Registration Number
- NCT00224107
- Lead Sponsor
- Watson Pharmaceuticals
- Brief Summary
A new drug for benign prostatic hyperplasia is compared to placebo for to determine if it is safe and effective. The study lasts approximately 20 weeks.
- Detailed Description
This will be a multi-center, double-blind, placebo controlled, parallel, 12 week treatment trial in men with signs and symptoms of benign prostatic hyperplasia. The following procedures are utilized: physical exams, electrocardiograms, clinical laboratory tests, vital signs, the International Prostate Symptom Score, maximum urine flow rate, pharmacokinetics, adverse events, concomitant medications, quality of life, and compliance.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 461
Inclusion Criteria
- Males in good general health and at least 50 years of age, with symptoms of moderate to severe benign prostatic hyperplasia.
Exclusion Criteria
- Medical conditions that would confound the efficacy evaluation.
- Medical conditions in which it would be unsafe to use an alpha-blocker.
- The use of concomitant drugs that would confound the efficacy evaluation.
- The use of concomitant drugs that would be unsafe with this alpha-blocker.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Silodosin Silodosin Silodosin 8 mg once daily with food placebo Placebo Matching Placebo capsule once daily with food
- Primary Outcome Measures
Name Time Method International Prostate Symptom Score (IPSS) 12 weeks Change from baseline In IPSS at Week 12. IPSS uses a 0 to 35 scale; 0 best, 35 worse symptoms
- Secondary Outcome Measures
Name Time Method Maximum Urine Flow Rate (Qmax) 12 weeks Change from baseline in maximum urine flow rate (Qmax)at Week 12