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:
NCT00224120
First received: September 14, 2005
Last updated: December 11, 2009
Last verified: December 2009
  Purpose

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 Intervention Phase
Benign Prostatic Hyperplasia
Drug: Silodosin
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Watson Pharmaceuticals:

Primary Outcome Measures:
  • Measuring Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change From Baseline in Maximum Urine Flow Rate (Qmax) at 12 Weeks [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 462
Study Start Date: May 2005
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Silodosin
Silodosin 8 mg/Day 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
One capsule daily for 12 weeks

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 Internation Prostate Symptom Score, maximum urine flow rate, pharmacokinetics, adverse events, concomitant medications, quality of life, and compliance.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders 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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00224120

  Show 42 Study Locations
Sponsors and Collaborators
Watson Pharmaceuticals
Investigators
Study Director: Lawrence Hill, PharmD, RPh Watson Pharmaceuticals
  More Information

Publications:
Additional 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: NCT00224120     History of Changes
Other Study ID Numbers: SI04010
Study First Received: September 14, 2005
Results First Received: September 8, 2009
Last Updated: December 11, 2009
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on July 20, 2014