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A New Drug for Benign Prostatic Hyperplasia (BPH) Compared With Placebo

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ClinicalTrials.gov Identifier: NCT00224107
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : December 3, 2009
Last Update Posted : July 12, 2011
Sponsor:
Information provided by:
Watson Pharmaceuticals

Brief Summary:
A new drug for benign prostatic hyperplasia is compared to placebo for to determine if it is safe and effective. The study lasts approximately 20 weeks.

Condition or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia (BPH) Drug: Silodosin Other: Placebo Phase 3

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. The following procedures are utilized: physical exams, electrocardiograms, clinical laboratory tests, vital signs, the International Prostate Symptom Score, maximum urine flow rate, pharmacokinetics, adverse events, concomitant medications, quality of life, and compliance.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 461 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized, Double-Blind, Placebo Controlled, Parallel Evaluation of the Efficacy and Safety of a New Drug in the Treatment of the Signs and Symptoms of Benign Prostatic Hyperplasia
Study Start Date : May 2005
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Silodosin

Arm Intervention/treatment
Experimental: Silodosin
Silodosin 8 mg once daily with food
Drug: Silodosin
8 mg daily for 12 weeks
Other Name: Rapaflo

Placebo Comparator: placebo
Matching Placebo capsule once daily with food
Other: Placebo
1 capsule daily for 12 weeks




Primary Outcome Measures :
  1. International Prostate Symptom Score (IPSS) [ Time Frame: 12 weeks ]
    Change from baseline In IPSS at Week 12. IPSS uses a 0 to 35 scale; 0 best, 35 worse symptoms


Secondary Outcome Measures :
  1. Maximum Urine Flow Rate (Qmax) [ Time Frame: 12 weeks ]
    Change from baseline in maximum urine flow rate (Qmax)at Week 12



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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 benign prostatic hyperplasia.

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): NCT00224107


  Show 43 Study Locations
Sponsors and Collaborators
Watson Pharmaceuticals
Investigators
Study Director: Lawrence Hill, PharmD, RPh Watson Pharmaceuticals

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gary Hoel, RPh, PhD, Executive Director of Clinical Research, Watson Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00224107     History of Changes
Other Study ID Numbers: SI04009
First Posted: September 22, 2005    Key Record Dates
Results First Posted: December 3, 2009
Last Update Posted: July 12, 2011
Last Verified: July 2011

Keywords provided by Watson Pharmaceuticals:
Benign prostatic hyperplasia, BPH, alpha blocker

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
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