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

This study has been completed.
Sponsor:
Information provided by:
Watson Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00224107
First received: September 14, 2005
Last updated: July 5, 2011
Last verified: July 2011
History of Changes

September 14, 2005
July 5, 2011
May 2005
August 2006   (final data collection date for primary outcome measure)
International Prostate Symptom Score (IPSS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Change from baseline In IPSS at Week 12. IPSS uses a 0 to 35 scale; 0 best, 35 worse symptoms
Change in baseline score on the International Prostate Symptom Score
Complete list of historical versions of study NCT00224107 on ClinicalTrials.gov Archive Site
Maximum Urine Flow Rate (Qmax) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Change from baseline in maximum urine flow rate (Qmax)at Week 12
Change in baseline urine flow rate Safety
Not Provided
Not Provided
 
A New Drug for Benign Prostatic Hyperplasia (BPH) Compared With Placebo
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

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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Benign Prostatic Hyperplasia (BPH)
  • Drug: Silodosin
    8 mg daily for 12 weeks
    Other Name: Rapaflo
  • Other: Placebo
    1 capsule daily for 12 weeks
  • Experimental: Silodosin
    Silodosin 8 mg once daily with food
    Intervention: Drug: Silodosin
  • Placebo Comparator: placebo
    Matching Placebo capsule once daily with food
    Intervention: Other: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
461
August 2006
August 2006   (final data collection date for primary outcome measure)

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.
Male
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00224107
SI04009
No
Gary Hoel, RPh, PhD, Executive Director of Clinical Research, Watson Laboratories, Inc.
Watson Pharmaceuticals
Not Provided
Study Director: Lawrence Hill, PharmD, RPh Watson Pharmaceuticals
Watson Pharmaceuticals
July 2011

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