Clinical trial NCT00224107: 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 (BPH)
Keywords: Benign prostatic hyperplasia, BPH, alpha blocker
Lead sponsor: Watson Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 461
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 International 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 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.

Primary outcomes:
measure: International Prostate Symptom Score (IPSS)
timeFrame: 12 weeks
Secondary outcomes:
measure: Maximum Urine Flow Rate (Qmax)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Huntsville
country: United States
state: Alabama
city: Tucson
country: United States
state: Arizona
city: Anaheim
country: United States
state: California
city: Culver City
country: United States
state: California
city: Irvine
country: United States
state: California
city: La Jolla
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Newport Beach
country: United States
state: California
city: San Diego
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Wheat Ridge
country: United States
state: Colorado
city: Waterbury
country: United States
state: Connecticut
city: Aventura
country: United States
state: Florida
city: Clearwater
country: United States
state: Florida
city: Coral Gables
country: United States
state: Florida
city: Pensacola
country: United States
state: Florida
city: Marietta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Peoria
country: United States
state: Illinois
city: Des Moines
country: United States
state: Iowa
city: St. Joseph
country: United States
state: Michigan
city: Edina
country: United States
state: Minnesota
city: Missoula
country: United States
state: Montana
city: Las Vegas
country: United States
state: Nevada
city: Bay Shore
country: United States
state: New York
city: Garden City
country: United States
state: New York
city: Manhasset
country: United States
state: New York
city: New York
country: United States
state: New York
city: Staten Island
country: United States
state: New York
city: Williamsville
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Salisbury
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Bethany
country: United States
state: Oklahoma
city: Portland
country: United States
state: Oregon
city: Lancaster
country: United States
state: Pennsylvania
city: Greer
country: United States
state: South Carolina
city: Dallas
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Lakewood
country: United States
state: Washington
city: Tacoma
country: United States
state: Washington
city: Milwaukee
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.