A New Drug for Benign Prostatic Hyperplasia (BPH) Compared With Placebo - Full Text View

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 (BPH)	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:

Drug Information available for: Silodosin

U.S. FDA Resources

Further study details as provided by Watson Pharmaceuticals:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	461
Study Start Date:	May 2005
Study Completion Date:	August 2006
Primary Completion Date:	August 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

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 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00224107

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Locations

United States, Alabama

Huntsville, Alabama, United States
United States, Arizona

Tucson, Arizona, United States
United States, California

Anaheim, California, United States

Culver City, California, United States

Irvine, California, United States

La Jolla, California, United States

Long Beach, California, United States

Newport Beach, California, United States

San Diego, California, United States
United States, Colorado

Aurora, Colorado, United States

Wheat Ridge, Colorado, United States
United States, Connecticut

Waterbury, Connecticut, United States
United States, Florida

Aventura, Florida, United States

Clearwater, Florida, United States

Coral Gables, Florida, United States

Pensacola, Florida, United States
United States, Georgia

Marietta, Georgia, United States
United States, Illinois

Chicago, Illinois, United States

Peoria, Illinois, United States
United States, Iowa

Des Moines, Iowa, United States
United States, Michigan

St. Joseph, Michigan, United States
United States, Minnesota

Edina, Minnesota, United States
United States, Montana

Missoula, Montana, United States
United States, Nevada

Las Vegas, Nevada, United States
United States, New York

Bay Shore, New York, United States

Garden City, New York, United States

Manhasset, New York, United States

New York, New York, United States

Staten Island, New York, United States

Williamsville, New York, United States
United States, North Carolina

Charlotte, North Carolina, United States

Salisbury, North Carolina, United States

Winston-Salem, North Carolina, United States
United States, Ohio

Cincinnati, Ohio, United States
United States, Oklahoma

Bethany, Oklahoma, United States
United States, Oregon

Portland, Oregon, United States
United States, Pennsylvania

Lancaster, Pennsylvania, United States
United States, South Carolina

Greer, South Carolina, United States
United States, Texas

Dallas, Texas, United States
United States, Utah

Salt Lake City, Utah, United States
United States, Washington

Lakewood, Washington, United States

Tacoma, Washington, United States
United States, Wisconsin

Milwaukee, Wisconsin, United States

Sponsors and Collaborators

Watson Pharmaceuticals

Investigators

Study Director:

Lawrence Hill, PharmD, RPh

Watson Pharmaceuticals

More Information

Publications:

Marks LS, Gittelman MC, Hill LA, Volinn W, Hoel G. Rapid efficacy of the highly selective alpha1A-adrenoceptor antagonist silodosin in men with signs and symptoms of benign prostatic hyperplasia: pooled results of 2 phase 3 studies. J Urol. 2009 Jun;181(6):2634-40. Epub 2009 Apr 16.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Marks LS, Gittelman MC, Hill LA, Volinn W, Hoel G. Rapid efficacy of the highly selective α(1A)-adrenoceptor antagonist silodosin in men with signs and symptoms of benign prostatic hyperplasia: pooled results of 2 phase 3 studies. J Urol. 2013 Jan;189(1 Suppl):S122-8. doi: 10.1016/j.juro.2012.11.020.

Roehrborn CG, Kaplan SA, Lepor H, Volinn W. Symptomatic and urodynamic responses in patients with reduced or no seminal emission during silodosin treatment for LUTS and BPH. Prostate Cancer Prostatic Dis. 2011 Jun;14(2):143-8. Epub 2010 Dec 7.

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
Study First Received:	September 14, 2005
Results First Received:	September 8, 2009
Last Updated:	July 5, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Watson Pharmaceuticals:

Benign prostatic hyperplasia, BPH, alpha blocker

Additional relevant MeSH terms:

Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013