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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00793819
First Posted: November 19, 2008
Last Update Posted: March 9, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Watson Pharmaceuticals
  Purpose
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
Nocturia Prostatic Hyperplasia Drug: silodosin Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00793819


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

Responsible Party: Watson Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00793819     History of Changes
Other Study ID Numbers: SI08005
First Submitted: November 17, 2008
First Posted: November 19, 2008
Results First Submitted: February 7, 2012
Results First Posted: March 9, 2012
Last Update Posted: March 9, 2012
Last Verified: February 2012

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

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Nocturia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Silodosin
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