Randomized, Double-Blind, Vehicle-Controlled, Multicenter Safety and Efficacy Study of Intraprostatic PRX302 for LUTS BPH
NCT ID: NCT01966614
Last Updated: 2017-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
479 participants
INTERVENTIONAL
2013-10-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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PRX302
PRX302 injection
PRX302
Single intraprostatic bilateral injection at a dose of 0.6 µg/g
Placebo
Placebo (Vehicle-only injection)
Placebo
Single intraprostatic bilateral injection of vehicle only
Interventions
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PRX302
Single intraprostatic bilateral injection at a dose of 0.6 µg/g
Placebo
Single intraprostatic bilateral injection of vehicle only
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Lower Urinary Tract Symptoms (LUTS) attributable to BPH for ≥6 months
* IPSS ≥15
* Maximum urine flow (Qmax) of 5 - 15 mL/sec
* Prostate volume of 30 - 100 mL as determined by TRUS
* Serum prostate-specific antigen (PSA) values \<10 ng/mL
* Post-void residual (PVR) \<= 200 mL
Exclusion Criteria
* Prior surgery/MIST for BPH
* Presence of or history of certain conditions that could interfere with study results or endanger subject
* Use of certain prescribed medications that could interfere with study results
50 Years
MALE
No
Sponsors
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Sophiris Bio Corp
INDUSTRY
Responsible Party
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Principal Investigators
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Richard C Yocum, MD
Role: STUDY_DIRECTOR
Sophiris Bio Corp
Locations
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Huntsville, Alabama, United States
Anchorage, Alaska, United States
Laguna Hills, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Newport Beach, California, United States
San Diego, California, United States
San Diego, California, United States
Tarzana, California, United States
Denver, Colorado, United States
Middlebury, Connecticut, United States
Aventura, Florida, United States
Coral Gables, Florida, United States
Pompano Beach, Florida, United States
St. Petersburg, Florida, United States
Wellington, Florida, United States
Coeur d'Alene, Idaho, United States
Meridian, Idaho, United States
Springfield, Illinois, United States
Jeffersonville, Indiana, United States
West Des Moines, Iowa, United States
Baltimore, Maryland, United States
Baltimore, Maryland, United States
Greenbelt, Maryland, United States
Towson, Maryland, United States
Brookline, Massachusetts, United States
Missoula, Montana, United States
Mount Laurel, New Jersey, United States
Albuquerque, New Mexico, United States
Garden City, New York, United States
New York, New York, United States
Newburgh, New York, United States
Poughkeepsie, New York, United States
The Bronx, New York, United States
Concord, North Carolina, United States
Raleigh, North Carolina, United States
Bala-Cynwyd, Pennsylvania, United States
Bryn Mawr, Pennsylvania, United States
Greer, South Carolina, United States
Myrtle Beach, South Carolina, United States
Carrollton, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
Burien, Washington, United States
Daw Park, South Australia, Australia
Woodville South, South Australia, Australia
Mentone, Victoria, Australia
Parkville, Victoria, Australia
Brampton, Ontario, Canada
Kitchener, Ontario, Canada
Oakville, Ontario, Canada
Whau Valley, Whangarei, New Zealand
Christchurch, , New Zealand
Tauranga, , New Zealand
Ivanovo, , Russia
Moscow, , Russia
Moscow, , Russia
Rostov-on-Don, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saratov, , Russia
Chernihiv, , Ukraine
Chernivtsi, , Ukraine
Dnipropetrovsk, , Ukraine
Kharkiv, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Lviv, , Ukraine
Lviv, , Ukraine
Zaporizhzhya, , Ukraine
Countries
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Other Identifiers
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PRX302-3-01
Identifier Type: -
Identifier Source: org_study_id
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