A Phase 2 interventional study of silodosin in Nocturia and Prostatic Hyperplasia, sponsored by Watson Pharmaceuticals. Completed at 27 sites in United States. Open to male participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2012-03-09.
Sponsored by Watson Pharmaceuticals · Phase 2, Interventional, and Treatment
Silodosin is compared to placebo to determine if it is safe and effective for the treatment of nighttime urination (nocturia) in men with BPH
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
783 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.
This study's enrollment of 215 is above the median of 97 across 593 interventional studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →Watson Pharmaceuticals is the lead sponsor of 30 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: silodosin
Drug: silodosin
α1-adrenergic antagonist
Also known as: Rapaflo
Change in Nocturia Episodes
Time frame: 12 weeks
| Milestone | Silodosin 8mg | Placebo |
|---|---|---|
| Started | 111 | 98 |
| Completed | 97 | 89 |
| Not completed | 14 | 9 |
| Withdrew: Adverse event | 8 | 4 |
| Withdrew: Lack of efficacy | 1 | 1 |
| Withdrew: Withdrawal by subject | 4 | 3 |
| Withdrew: Lost to follow-up | 1 | 1 |
| episodes | Silodosin 8mg | Placebo |
|---|---|---|
| Change in Nocturia Episodes | -1.2 ± 1.35 | -1.0 ± 1.44 |
Collected over 12 weeks. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Silodosin 8mg | — | 1/111 (0.9%) | 39/111 (35.1%) |
| Placebo | — | 1/98 (1%) | 21/98 (21.4%) |
| Event | Silodosin 8mg | Placebo |
|---|---|---|
| Multiple Bone FractureMusculoskeletal and connective tissue disorders | 0/111 | 1/98 |
| CellulitisInfections and infestations | 1/111 | 0/98 |
| Event | Silodosin 8mg | Placebo |
|---|---|---|
| Retrograde EjaculationReproductive system and breast disorders | 24/111 | 0/98 |
| InsomniaPsychiatric disorders | 2/111 | 5/98 |
| HeadacheNervous system disorders | 5/111 | 1/98 |
| DiarrhoeaGastrointestinal disorders | 3/111 | 4/98 |
| Back PainMusculoskeletal and connective tissue disorders | 4/111 | 3/98 |
| DizzinessNervous system disorders | 4/111 | 3/98 |
| FatigueGeneral disorders | 4/111 | 1/98 |
| Urinary Track InfectionInfections and infestations | 0/111 | 3/98 |
| Nasal CongestionRespiratory, thoracic and mediastinal disorders | 3/111 | 0/98 |
| Musculoskeletal PainMusculoskeletal and connective tissue disorders | 2/111 | 2/98 |
| Age, Categorical(Participants) | Silodosin 8mg | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 63 | 62 | 125 |
| >=65 years | 48 | 36 | 84 |
| Age Continuous(years) | Silodosin 8mg | Placebo | Total |
|---|---|---|---|
| Mean | 64.6 ± 8.03 | 64.2 ± 8.92 | 64.4 ± 8.44 |
| Sex: Female, Male(Participants) | Silodosin 8mg | Placebo | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 111 | 98 | 209 |
| Region of Enrollment(participants) | Silodosin 8mg | Placebo | Total |
|---|---|---|---|
| United States | 111 | 98 | 209 |
This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.
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Watson Pharmaceuticals