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

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ClinicalTrials.gov Identifier: NCT00793819
Recruitment Status : Completed
First Posted : November 19, 2008
Results First Posted : March 9, 2012
Last Update Posted : March 9, 2012
Sponsor:
Information provided by (Responsible Party):
Watson Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Nocturia Prostatic Hyperplasia Drug: silodosin Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 215 participants
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
Study Start Date : January 2009
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Silodosin

Arm Intervention/treatment
Experimental: 1 Silodosin Drug: silodosin
α1-adrenergic antagonist
Other Name: Rapaflo

Placebo Comparator: 2 Placebo Drug: silodosin
α1-adrenergic antagonist
Other Name: Rapaflo




Primary Outcome Measures :
  1. Change in Nocturia Episodes [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
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.

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

Responsible Party: Watson Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00793819     History of Changes
Other Study ID Numbers: SI08005
First Posted: November 19, 2008    Key Record Dates
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:
Silodosin
Hyperplasia
Prostatic Hyperplasia
Nocturia
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