Clinical trial NCT00224120: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Benign Prostatic Hyperplasia
Keywords: Benign prostatic hyperplasia, alpha blocker
Lead sponsor: Watson Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 462
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Measuring Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Change From Baseline in Maximum Urine Flow Rate (Qmax) at 12 Weeks
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Carmichael
country: United States
state: California
city: Fresno
country: United States
state: California
city: Laguna Woods
country: United States
state: California
city: San Bernardino
country: United States
state: California
city: Tarzana
country: United States
state: California
city: Torrance
country: United States
state: California
city: New Port Richey
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Plantation
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Melrose Park
country: United States
state: Illinois
city: Evansville
country: United States
state: Indiana
city: Fort Wayne
country: United States
state: Indiana
city: Overland Park
country: United States
state: Kansas
city: Greenbelt
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Jackson
country: United States
state: Mississippi
city: Kansas City
country: United States
state: Missouri
city: Lawrenceville
country: United States
state: New Jersey
city: Voorhees
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Albany
country: United States
state: New York
city: Garden City
country: United States
state: New York
city: Kingston
country: United States
state: New York
city: Poughkeepsie
country: United States
state: New York
city: Concord
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Providence
country: United States
state: Rhode Island
city: Mt. Pleasant
country: United States
state: South Carolina
city: Myrtle Beach
country: United States
state: South Carolina
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Norfolk
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Tacoma
country: United States
state: Washington
city: Madison
country: United States
state: Wisconsin
Study officials:
affiliation: Watson Pharmaceuticals
name: Lawrence Hill, PharmD, RPh
role: STUDY_DIRECTOR
References:
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.
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.
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.