A Study of Silodosin 8 mg Daily for the Treatment of Nocturia in Men With Benign Prostatic Hyperplasia

Watson Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Nocturia; Prostatic Hyperplasia

Treatments: Drug: silodosin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00793819

SI08005

Details and patient eligibility

About

Silodosin is compared to placebo to determine if it is safe and effective for the treatment of nighttime urination (nocturia) in men with BPH

Full 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

Enrollment: 215 patients

Sex: Male

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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215 participants in 2 patient groups, including a placebo group

1 Silodosin

Experimental group

Treatment:

Drug: silodosin

2 Placebo

Placebo Comparator group

Treatment:

Drug: silodosin