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

Primary Purpose

Benign Prostatic Hyperplasia

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 focused on measuring Benign prostatic hyperplasia, 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 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Silodosin

Placebo

Arm Description

Silodosin 8 mg/Day with food

Matching placebo capsule once daily with food

Outcomes

Primary Outcome Measures

Measuring Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks
International prostate symptom score: Measuring prostate signs and symptoms asociated with benign prostatic hyperplasia on a 0 to 35 scale; 0 best, 35 worst symptoms

Secondary Outcome Measures

Change From Baseline in Maximum Urine Flow Rate (Qmax) at 12 Weeks

Full Information

First Posted
September 14, 2005
Last Updated
December 11, 2009
Sponsor
Watson Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00224120
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
December 2009
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
May 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 Internation 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
Keywords
Benign prostatic hyperplasia, alpha blocker

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Silodosin
Arm Type
Experimental
Arm Description
Silodosin 8 mg/Day 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
One capsule daily for 12 weeks
Primary Outcome Measure Information:
Title
Measuring Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks
Description
International prostate symptom score: Measuring prostate signs and symptoms asociated with benign prostatic hyperplasia on a 0 to 35 scale; 0 best, 35 worst symptoms
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Maximum Urine Flow Rate (Qmax) at 12 Weeks
Time Frame
Baseline and 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 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.
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
Birmingham
State/Province
Alabama
Country
United States
City
Carmichael
State/Province
California
Country
United States
City
Fresno
State/Province
California
Country
United States
City
Laguna Woods
State/Province
California
Country
United States
City
San Bernardino
State/Province
California
Country
United States
City
Tarzana
State/Province
California
Country
United States
City
Torrance
State/Province
California
Country
United States
City
New Port Richey
State/Province
Florida
Country
United States
City
Ocala
State/Province
Florida
Country
United States
City
Orlando
State/Province
Florida
Country
United States
City
Plantation
State/Province
Florida
Country
United States
City
Tampa
State/Province
Florida
Country
United States
City
West Palm Beach
State/Province
Florida
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Melrose Park
State/Province
Illinois
Country
United States
City
Evansville
State/Province
Indiana
Country
United States
City
Fort Wayne
State/Province
Indiana
Country
United States
City
Overland Park
State/Province
Kansas
Country
United States
City
Greenbelt
State/Province
Maryland
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
City
Jackson
State/Province
Mississippi
Country
United States
City
Kansas City
State/Province
Missouri
Country
United States
City
Lawrenceville
State/Province
New Jersey
Country
United States
City
Voorhees
State/Province
New Jersey
Country
United States
City
Albuquerque
State/Province
New Mexico
Country
United States
City
Albany
State/Province
New York
Country
United States
City
Garden City
State/Province
New York
Country
United States
City
Kingston
State/Province
New York
Country
United States
City
Poughkeepsie
State/Province
New York
Country
United States
City
Concord
State/Province
North Carolina
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Portland
State/Province
Oregon
Country
United States
City
Providence
State/Province
Rhode Island
Country
United States
City
Mt. Pleasant
State/Province
South Carolina
Country
United States
City
Myrtle Beach
State/Province
South Carolina
Country
United States
City
Austin
State/Province
Texas
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Norfolk
State/Province
Virginia
Country
United States
City
Seattle
State/Province
Washington
Country
United States
City
Tacoma
State/Province
Washington
Country
United States
City
Madison
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
background
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

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

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