Nocturia, Prostatic Hyperplasia
Conditions
Keywords
nocturia, BPH, benign prostate hyperplasia, nocturia in men with benign prostate hyperplasia
Brief summary
Silodosin is compared to placebo to determine if it is safe and effective for the treatment of nighttime urination (nocturia) in men with BPH
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 and nocturia. The following procedures are utilized; physical exams, electrocardiograms, clinical laboratory tests, vital signs, urinary diary, Pittsburgh Quality of Sleep Index, Nocturia Quality of Life
Interventions
DRUGsilodosin
α1-adrenergic antagonist
Sponsors
Watson Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
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 and nocturia (\>=2 episodes per night)
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 |
|---|---|
| Change in Nocturia Episodes | 12 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Silodosin 8mg Silodosin 8mg daily | 111 |
| Placebo 1 placebo capsule daily | 98 |
| Total | 209 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 8 | 4 |
| Overall Study | Lack of Efficacy | 1 | 1 |
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 3 |
Baseline characteristics
| Characteristic | Placebo | Silodosin 8mg | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 36 Participants | 48 Participants | 84 Participants |
| Age, Categorical Between 18 and 65 years | 62 Participants | 63 Participants | 125 Participants |
| Age Continuous | 64.2 years STANDARD_DEVIATION 8.92 | 64.6 years STANDARD_DEVIATION 8.03 | 64.4 years STANDARD_DEVIATION 8.44 |
| Region of Enrollment United States | 98 participants | 111 participants | 209 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 98 Participants | 111 Participants | 209 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 39 / 111 | 21 / 98 |
| serious Total, serious adverse events | 1 / 111 | 1 / 98 |
Outcome results
Primary
Change in Nocturia Episodes
Time frame: 12 weeks
Population: The number of participants for analysis is determined by Last Observation Carried Forward (LOCF).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Silodosin 8mg | Change in Nocturia Episodes | -1.2 episodes | Standard Deviation 1.35 |
| Placebo | Change in Nocturia Episodes | -1.0 episodes | Standard Deviation 1.44 |