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

This study has been completed.
Information provided by (Responsible Party):
Watson Pharmaceuticals Identifier:
First received: November 17, 2008
Last updated: February 7, 2012
Last verified: February 2012
Silodosin is compared to placebo to determine if it is safe and effective for the treatment of nighttime urination (nocturia) in men with BPH

Condition Intervention Phase
Prostatic Hyperplasia
Drug: silodosin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Phase 2 Study of Silodosin 8 mg Daily for the Treatment of Nocturia in Men With Benign Prostatic Hyperplasia

Resource links provided by NLM:

Further study details as provided by Watson Pharmaceuticals:

Primary Outcome Measures:
  • Change in Nocturia Episodes [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 215
Study Start Date: January 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Silodosin Drug: silodosin
α1-adrenergic antagonist
Other Name: Rapaflo
Placebo Comparator: 2 Placebo Drug: silodosin
α1-adrenergic antagonist
Other Name: Rapaflo

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

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Genders Eligible for Study:   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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00793819

  Show 27 Study Locations
Sponsors and Collaborators
Watson Pharmaceuticals
Study Director: Kim Caramelli, MS Watson Pharmaceuticals
  More Information

Responsible Party: Watson Pharmaceuticals Identifier: NCT00793819     History of Changes
Other Study ID Numbers: SI08005 
Study First Received: November 17, 2008
Results First Received: February 7, 2012
Last Updated: February 7, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Watson Pharmaceuticals:
benign prostate hyperplasia
nocturia in men with benign prostate hyperplasia

Additional relevant MeSH terms:
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents processed this record on October 27, 2016