A New Drug for Benign Prostatic Hyperplasia (BPH) Compared With Placebo
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
1 other identifier
interventional
462
1 country
42
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2005
Shorter than P25 for phase_3
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 14, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2006
CompletedResults Posted
Study results publicly available
December 3, 2009
CompletedDecember 15, 2009
December 1, 2009
1 year
September 14, 2005
September 8, 2009
December 11, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Baseline and 12 weeks
Secondary Outcomes (1)
Change From Baseline in Maximum Urine Flow Rate (Qmax) at 12 Weeks
Baseline and 12 weeks
Study Arms (2)
Silodosin
EXPERIMENTALSilodosin 8 mg/Day with food
Placebo
PLACEBO COMPARATORMatching placebo capsule once daily with food
Interventions
Eligibility Criteria
You may qualify if:
- Males in good general health and at least 50 years of age, with symptoms of moderate to severe BPH.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (42)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Carmichael, California, United States
Unknown Facility
Fresno, California, United States
Unknown Facility
Laguna Woods, California, United States
Unknown Facility
San Bernardino, California, United States
Unknown Facility
Tarzana, California, United States
Unknown Facility
Torrance, California, United States
Unknown Facility
New Port Richey, Florida, United States
Unknown Facility
Ocala, Florida, United States
Unknown Facility
Orlando, Florida, United States
Unknown Facility
Plantation, Florida, United States
Unknown Facility
Tampa, Florida, United States
Unknown Facility
West Palm Beach, Florida, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Melrose Park, Illinois, United States
Unknown Facility
Evansville, Indiana, United States
Unknown Facility
Fort Wayne, Indiana, United States
Unknown Facility
Overland Park, Kansas, United States
Unknown Facility
Greenbelt, Maryland, United States
Unknown Facility
Boston, Massachusetts, United States
Unknown Facility
Jackson, Mississippi, United States
Unknown Facility
Kansas City, Missouri, United States
Unknown Facility
Lawrenceville, New Jersey, United States
Unknown Facility
Voorhees Township, New Jersey, United States
Unknown Facility
Albuquerque, New Mexico, United States
Unknown Facility
Albany, New York, United States
Unknown Facility
Garden City, New York, United States
Unknown Facility
Kingston, New York, United States
Unknown Facility
Poughkeepsie, New York, United States
Unknown Facility
Concord, North Carolina, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Portland, Oregon, United States
Unknown Facility
Providence, Rhode Island, United States
Unknown Facility
Mt. Pleasant, South Carolina, United States
Unknown Facility
Myrtle Beach, South Carolina, United States
Unknown Facility
Austin, Texas, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Norfolk, Virginia, United States
Unknown Facility
Seattle, Washington, United States
Unknown Facility
Tacoma, Washington, United States
Unknown Facility
Madison, Wisconsin, United States
Related Publications (3)
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.
PMID: 19371887BACKGROUNDMarks 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.
PMID: 23234617DERIVEDRoehrborn 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.
PMID: 21135869DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gary Hoel, RPh, PhD, Executive Director of Clinical Research
- Organization
- Watson Laboratories, Inc.
Study Officials
- STUDY DIRECTOR
Lawrence Hill, PharmD, RPh
Watson Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 14, 2005
First Posted
September 22, 2005
Study Start
May 1, 2005
Primary Completion
May 1, 2006
Study Completion
May 1, 2006
Last Updated
December 15, 2009
Results First Posted
December 3, 2009
Record last verified: 2009-12