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

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.
 
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

Tracking Information
First Submitted Date  ICMJE November 17, 2008
First Posted Date  ICMJE November 19, 2008
Results First Submitted Date  ICMJE February 7, 2012
Results First Posted Date  ICMJE March 9, 2012
Last Update Posted Date March 9, 2012
Study Start Date  ICMJE January 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2008)
Change in Nocturia Episodes [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2008)
Change in quality of life questionnaire responses [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Silodosin 8 mg Daily for the Treatment of Nocturia in Men With Benign Prostatic Hyperplasia
Official Title  ICMJE A Double-Blind, Placebo-Controlled Phase 2 Study of Silodosin 8 mg Daily for the Treatment of Nocturia in Men With Benign Prostatic Hyperplasia
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Nocturia
  • Prostatic Hyperplasia
Intervention  ICMJE Drug: silodosin
α1-adrenergic antagonist
Other Name: Rapaflo
Study Arms  ICMJE
  • Experimental: 1 Silodosin
    Intervention: Drug: silodosin
  • Placebo Comparator: 2 Placebo
    Intervention: Drug: silodosin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 26, 2009)
215
Original Estimated Enrollment  ICMJE
 (submitted: November 18, 2008)
200
Actual Study Completion Date  ICMJE October 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00793819
Other Study ID Numbers  ICMJE SI08005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Watson Pharmaceuticals
Study Sponsor  ICMJE Watson Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Kim Caramelli, MS Watson Pharmaceuticals
PRS Account Watson Pharmaceuticals
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP