Benign Prostatic Hyperplasia (BPH)
Conditions
Keywords
Benign prostatic hyperplasia, BPH, alpha blocker
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.
Interventions
DRUGSilodosin
8 mg daily for 12 weeks
OTHERPlacebo
1 capsule daily for 12 weeks
Sponsors
Watson Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Maximum Urine Flow Rate (Qmax) | 12 weeks | Change from baseline in maximum urine flow rate (Qmax)at Week 12 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Silodosin Silodosin 8 mg once daily with food | 233 |
| Placebo Matching placebo capsule once daily with food | 228 |
| Total | 461 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 20 | 6 |
| Overall Study | Lack of Efficacy | 2 | 0 |
| Overall Study | Lost to Follow-up | 4 | 0 |
| Overall Study | Other | 1 | 1 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Protocol Violation | 2 | 3 |
| Overall Study | Withdrawal by Subject | 1 | 4 |
Baseline characteristics
| Characteristic | Placebo | Silodosin | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 98 Participants | 97 Participants | 195 Participants |
| Age, Categorical Between 18 and 65 years | 130 Participants | 136 Participants | 266 Participants |
| Age Continuous | 64.0 years STANDARD_DEVIATION 7.84 | 64.4 years STANDARD_DEVIATION 7.94 | 64.2 years STANDARD_DEVIATION 7.88 |
| Region of Enrollment United States | 228 participants | 233 participants | 461 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 228 Participants | 233 Participants | 461 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 116 / 233 | 24 / 228 |
| serious Total, serious adverse events | 3 / 233 | 3 / 228 |
Outcome results
Primary
International Prostate Symptom Score (IPSS)
Change from baseline In IPSS at Week 12. IPSS uses a 0 to 35 scale; 0 best, 35 worse symptoms
Time frame: 12 weeks
Population: The number of participants for analysis is determined by Last Observation Carried Forward (LOCF).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Silodosin | International Prostate Symptom Score (IPSS) | Baseline IPSS | 21.5 Units on a 0 to 35 scale | Standard Deviation 5.38 |
| Silodosin | International Prostate Symptom Score (IPSS) | Change from Baseline in IPSS at Week 12 | -6.5 Units on a 0 to 35 scale | Standard Deviation 6.73 |
| Placebo | International Prostate Symptom Score (IPSS) | Baseline IPSS | 21.4 Units on a 0 to 35 scale | Standard Deviation 4.91 |
| Placebo | International Prostate Symptom Score (IPSS) | Change from Baseline in IPSS at Week 12 | -3.6 Units on a 0 to 35 scale | Standard Deviation 5.85 |
Secondary
Maximum Urine Flow Rate (Qmax)
Change from baseline in maximum urine flow rate (Qmax)at Week 12
Time frame: 12 weeks
Population: The number of participants for analysis is determined by Last Observation Carried Forward (LOCF).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Silodosin | Maximum Urine Flow Rate (Qmax) | Baseline Qmax | 9.0 mL/sec | Standard Deviation 2.6 |
| Silodosin | Maximum Urine Flow Rate (Qmax) | Change from Baseline in Qmax at Week 12 | 2.2 mL/sec | Standard Deviation 4.31 |
| Placebo | Maximum Urine Flow Rate (Qmax) | Baseline Qmax | 9.0 mL/sec | Standard Deviation 2.85 |
| Placebo | Maximum Urine Flow Rate (Qmax) | Change from Baseline in Qmax at Week 12 | 1.2 mL/sec | Standard Deviation 3.81 |