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
461
1 country
43
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
43 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
August 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2006
CompletedResults Posted
Study results publicly available
December 3, 2009
CompletedJuly 12, 2011
July 1, 2011
1.3 years
September 14, 2005
September 8, 2009
July 5, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
International Prostate Symptom Score (IPSS)
Change from baseline In IPSS at Week 12. IPSS uses a 0 to 35 scale; 0 best, 35 worse symptoms
12 weeks
Secondary Outcomes (1)
Maximum Urine Flow Rate (Qmax)
12 weeks
Study Arms (2)
Silodosin
EXPERIMENTALSilodosin 8 mg once daily 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 benign prostatic hyperplasia.
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 (43)
Unknown Facility
Huntsville, Alabama, United States
Unknown Facility
Tucson, Arizona, United States
Unknown Facility
Anaheim, California, United States
Unknown Facility
Culver City, California, United States
Unknown Facility
Irvine, California, United States
Unknown Facility
La Jolla, California, United States
Unknown Facility
Long Beach, California, United States
Unknown Facility
Newport Beach, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
Aurora, Colorado, United States
Unknown Facility
Wheat Ridge, Colorado, United States
Unknown Facility
Waterbury, Connecticut, United States
Unknown Facility
Aventura, Florida, United States
Unknown Facility
Clearwater, Florida, United States
Unknown Facility
Coral Gables, Florida, United States
Unknown Facility
Pensacola, Florida, United States
Unknown Facility
Marietta, Georgia, United States
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Chicago, Illinois, United States
Unknown Facility
Peoria, Illinois, United States
Unknown Facility
Des Moines, Iowa, United States
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Saint Joseph, Michigan, United States
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Edina, Minnesota, United States
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Missoula, Montana, United States
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Las Vegas, Nevada, United States
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Bay Shore, New York, United States
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Garden City, New York, United States
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Manhasset, New York, United States
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New York, New York, United States
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Staten Island, New York, United States
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Williamsville, New York, United States
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Charlotte, North Carolina, United States
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Salisbury, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Bethany, Oklahoma, United States
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Portland, Oregon, United States
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Lancaster, Pennsylvania, United States
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Greer, South Carolina, United States
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Dallas, Texas, United States
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Salt Lake City, Utah, United States
Unknown Facility
Lakewood, Washington, United States
Unknown Facility
Tacoma, Washington, United States
Unknown Facility
Milwaukee, 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: 19371887RESULTMarks 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
August 1, 2006
Study Completion
August 1, 2006
Last Updated
July 12, 2011
Results First Posted
December 3, 2009
Record last verified: 2011-07