NCT00793819CompletedPhase 2
A Double-Blind, Placebo-Controlled Phase 2 Study of Silodosin 8 mg Daily for the Treatment of Nocturia in Men With Benign Prostatic Hyperplasia
Watson Pharmaceuticals1 site in 1 country215 target enrollmentStarted: January 2009Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 215
- Locations
- 1
- Primary Endpoint
- Change in Nocturia Episodes
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts 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.
Arms & Interventions
1 Silodosin
Experimental
Intervention: silodosin (Drug)
2 Placebo
Placebo Comparator
Intervention: silodosin (Drug)
Outcomes
Primary Outcomes
Change in Nocturia Episodes
Time Frame: 12 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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