Phase 2
N=209
A Study of Silodosin 8 mg Daily for the Treatment of Nocturia in Men With Benign Prostatic Hyperplasia
Nocturia · Prostatic Hyperplasia
Bottom Line
View on ClinicalTrials.gov: NCT00793819 ↗Enrolled (actual)
209
Serious AEs
1.0%
Results posted
Mar 2012
Primary outcome: Primary: Change in Nocturia Episodes — -1.2; -1.0 episodes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- silodosin (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- Male
- Sponsor
- Watson Pharmaceuticals
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Nocturia Episodes |
-1.2; -1.0 | — |
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
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00793819). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.