Benign Prostatic Hyperplasia
Conditions
Keywords
Benign prostatic hyperplasia, 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 Internation 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
One 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 BPH.
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 |
|---|---|---|
| Measuring Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks | Baseline and 12 weeks | International prostate symptom score: Measuring prostate signs and symptoms asociated with benign prostatic hyperplasia on a 0 to 35 scale; 0 best, 35 worst symptoms |
Secondary
| Measure | Time frame |
|---|---|
| Change From Baseline in Maximum Urine Flow Rate (Qmax) at 12 Weeks | Baseline and 12 weeks |
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 | 229 |
| Total | 462 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 10 | 4 |
| Overall Study | Lack of Efficacy | 0 | 2 |
| Overall Study | Lost to Follow-up | 2 | 3 |
| Overall Study | Other | 4 | 5 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 5 | 10 |
Baseline characteristics
| Characteristic | Total | Silodosin | Placebo |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 220 Participants | 110 Participants | 110 Participants |
| Age, Categorical Between 18 and 65 years | 242 Participants | 123 Participants | 119 Participants |
| Age Continuous | 65.1 years STANDARD_DEVIATION 8.21 | 64.8 years STANDARD_DEVIATION 8.21 | 65.3 years STANDARD_DEVIATION 8.23 |
| Region of Enrollment United States | 462 participants | 233 participants | 229 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 462 Participants | 233 Participants | 229 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 99 / 233 | 15 / 229 |
| serious Total, serious adverse events | 3 / 233 | 4 / 229 |
Outcome results
Primary
Measuring Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks
International prostate symptom score: Measuring prostate signs and symptoms asociated with benign prostatic hyperplasia on a 0 to 35 scale; 0 best, 35 worst symptoms
Time frame: Baseline and 12 weeks
Population: The number of participants for analysis is determined by Last Observation Carried Forward (LOCF).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Silodosin | Measuring Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks | Change from baseline in IPSS at Week 12 | -6.3 Units on a scale | Standard Deviation 6.54 |
| Silodosin | Measuring Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks | Baseline IPSS | 21.2 Units on a scale | Standard Deviation 4.88 |
| Placebo | Measuring Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks | Baseline IPSS | 21.2 Units on a scale | Standard Deviation 4.92 |
| Placebo | Measuring Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks | Change from baseline in IPSS at Week 12 | -3.4 Units on a scale | Standard Deviation 5.83 |
Secondary
Change From Baseline in Maximum Urine Flow Rate (Qmax) at 12 Weeks
Time frame: Baseline and 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Silodosin | Change From Baseline in Maximum Urine Flow Rate (Qmax) at 12 Weeks | Baseline Qmax | 8.4 mL/min | Standard Deviation 2.48 |
| Silodosin | Change From Baseline in Maximum Urine Flow Rate (Qmax) at 12 Weeks | Change from baseline in Qmax at Week 12 | 2.9 mL/min | Standard Deviation 4.53 |
| Placebo | Change From Baseline in Maximum Urine Flow Rate (Qmax) at 12 Weeks | Baseline Qmax | 8.7 mL/min | Standard Deviation 2.67 |
| Placebo | Change From Baseline in Maximum Urine Flow Rate (Qmax) at 12 Weeks | Change from baseline in Qmax at Week 12 | 1.9 mL/min | Standard Deviation 4.82 |