Clinical trial NCT00793819: A Study of Silodosin 8 mg Daily for the Treatment of Nocturia in Men With Benign Prostatic Hyperplasia
Official title: A Double-Blind, Placebo-Controlled Phase 2 Study of Silodosin 8 mg Daily for the Treatment of Nocturia in Men With Benign Prostatic Hyperplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nocturia
Prostatic Hyperplasia
Keywords: nocturia
BPH
benign prostate hyperplasia
nocturia in men with benign prostate hyperplasia
Lead sponsor: Watson Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-11-19
Enrollment: 215
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: Silodosin is compared to placebo to determine if it is safe and effective for the treatment of nighttime urination (nocturia) in men with BPH

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 and nocturia. The following procedures are utilized; physical exams, electrocardiograms, clinical laboratory tests, vital signs, urinary diary, Pittsburgh Quality of Sleep Index, Nocturia Quality of Life

Eligibility criteria: Inclusion Criteria:

* Males in good general health and at least 50 years of age, with symptoms of moderate to severe BPH and nocturia (\>=2 episodes per night)

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: Change in Nocturia Episodes
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Watson Investigational Site
state: Alabama
city: Laguna Hills
country: United States
facility: Watson Investigational Site
state: California
city: San Diego
country: United States
facility: Watson Investigational Site
state: California
city: Aventura
country: United States
facility: Watson Investigational Site
state: Florida
city: Clearwater
country: United States
facility: Watson Investigational Site
state: Florida
city: Orlando
country: United States
facility: Watson Investigational Site
state: Florida
city: Marietta
country: United States
facility: Watson Investigational Site
state: Georgia
city: Sandy Springs
country: United States
facility: Watson Investigational Site
state: Georgia
city: Coeur d'Alene
country: United States
facility: Watson Investigational Site
state: Idaho
city: West Des Moines
country: United States
facility: Watson Investigational Site
state: Iowa
city: Paducah
country: United States
facility: Watson Investigational Site
state: Kentucky
city: Greenbelt
country: United States
facility: Watson Investigational Site
state: Maryland
city: Troy
country: United States
facility: Watson Investigational Site
state: Michigan
city: Missoula
country: United States
facility: Watson Investigational Site
state: Montana
city: Omaha
country: United States
facility: Watson Investigational Site
state: Nebraska
city: Las Vegas
country: United States
facility: Watson Investigational Site
state: Nevada
city: Lawrenceville
country: United States
facility: Watson Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: Watson Investigational Site
state: New Mexico
city: Bay Shore
country: United States
facility: Watson Investigational Site
state: New York
city: New York
country: United States
facility: Watson Investigational Site
state: New York
city: Williamsville
country: United States
facility: Watson Investigational Site
state: New York
city: Concord
country: United States
facility: Watson Investigational Site
state: North Carolina
city: Salisbury
country: United States
facility: Watson Investigational Site
state: North Carolina
city: Bethany
country: United States
facility: Watson Investigational Site
state: Oklahoma
city: Bala Cynwyd
country: United States
facility: Watson Investigational Site
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Watson Investigational Site
state: South Carolina
city: Burien
country: United States
facility: Watson Investigational Site
state: Washington
Study officials:
affiliation: Watson Pharmaceuticals
name: Kim Caramelli, MS
role: STUDY_DIRECTOR
References: