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

Primary Purpose

Benign Prostatic Hyperplasia (BPH)

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Silodosin
Placebo
Sponsored by
Watson Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia (BPH) focused on measuring Benign prostatic hyperplasia, BPH, alpha blocker

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Silodosin

placebo

Arm Description

Silodosin 8 mg once daily with food

Matching Placebo capsule once daily with food

Outcomes

Primary Outcome Measures

International Prostate Symptom Score (IPSS)
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)
Change from baseline in maximum urine flow rate (Qmax)at Week 12

Full Information

First Posted
September 14, 2005
Last Updated
July 5, 2011
Sponsor
Watson Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00224107
Brief Title
A New Drug for Benign Prostatic Hyperplasia (BPH) Compared With Placebo
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 Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Watson Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia (BPH)
Keywords
Benign prostatic hyperplasia, BPH, alpha blocker

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
461 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Silodosin
Arm Type
Experimental
Arm Description
Silodosin 8 mg once daily with food
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Matching Placebo capsule once daily with food
Intervention Type
Drug
Intervention Name(s)
Silodosin
Other Intervention Name(s)
Rapaflo
Intervention Description
8 mg daily for 12 weeks
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
1 capsule daily for 12 weeks
Primary Outcome Measure Information:
Title
International Prostate Symptom Score (IPSS)
Description
Change from baseline In IPSS at Week 12. IPSS uses a 0 to 35 scale; 0 best, 35 worse symptoms
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Maximum Urine Flow Rate (Qmax)
Description
Change from baseline in maximum urine flow rate (Qmax)at Week 12
Time Frame
12 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence Hill, PharmD, RPh
Organizational Affiliation
Watson Pharmaceuticals
Official's Role
Study Director
Facility Information:
City
Huntsville
State/Province
Alabama
Country
United States
City
Tucson
State/Province
Arizona
Country
United States
City
Anaheim
State/Province
California
Country
United States
City
Culver City
State/Province
California
Country
United States
City
Irvine
State/Province
California
Country
United States
City
La Jolla
State/Province
California
Country
United States
City
Long Beach
State/Province
California
Country
United States
City
Newport Beach
State/Province
California
Country
United States
City
San Diego
State/Province
California
Country
United States
City
Aurora
State/Province
Colorado
Country
United States
City
Wheat Ridge
State/Province
Colorado
Country
United States
City
Waterbury
State/Province
Connecticut
Country
United States
City
Aventura
State/Province
Florida
Country
United States
City
Clearwater
State/Province
Florida
Country
United States
City
Coral Gables
State/Province
Florida
Country
United States
City
Pensacola
State/Province
Florida
Country
United States
City
Marietta
State/Province
Georgia
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Peoria
State/Province
Illinois
Country
United States
City
Des Moines
State/Province
Iowa
Country
United States
City
St. Joseph
State/Province
Michigan
Country
United States
City
Edina
State/Province
Minnesota
Country
United States
City
Missoula
State/Province
Montana
Country
United States
City
Las Vegas
State/Province
Nevada
Country
United States
City
Bay Shore
State/Province
New York
Country
United States
City
Garden City
State/Province
New York
Country
United States
City
Manhasset
State/Province
New York
Country
United States
City
New York
State/Province
New York
Country
United States
City
Staten Island
State/Province
New York
Country
United States
City
Williamsville
State/Province
New York
Country
United States
City
Charlotte
State/Province
North Carolina
Country
United States
City
Salisbury
State/Province
North Carolina
Country
United States
City
Winston-Salem
State/Province
North Carolina
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Bethany
State/Province
Oklahoma
Country
United States
City
Portland
State/Province
Oregon
Country
United States
City
Lancaster
State/Province
Pennsylvania
Country
United States
City
Greer
State/Province
South Carolina
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States
City
Lakewood
State/Province
Washington
Country
United States
City
Tacoma
State/Province
Washington
Country
United States
City
Milwaukee
State/Province
Wisconsin
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19371887
Citation
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. doi: 10.1016/j.juro.2009.02.034. Epub 2009 Apr 16.
Results Reference
result
PubMed Identifier
23234617
Citation
Marks LS, Gittelman MC, Hill LA, Volinn W, Hoel G. Rapid efficacy of the highly selective alpha(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.
Results Reference
derived
PubMed Identifier
21135869
Citation
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. doi: 10.1038/pcan.2010.46. Epub 2010 Dec 7.
Results Reference
derived

Learn more about this trial

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

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