Incidence of Immediate Onset Systemic Allergic Reactions in Patients Treated With Plenaxis®
This is a postmarketing patient safety study in the FDA indicated population of patients
receiving Plenaxis®. On a quarterly basis, patients enrolled in the Plenaxis® Experience
Study will have their charts audited to record the number of immediate-onset systemic
allergic reactions that may occur while receiving Plenaxis®. The study will close when
2,000 patients have been enrolled. If immediate onset allergic reactions occur, patients
may be eligible to enroll in a second protocol (skin testing in patients who experience an
immediate onset allergic reaction). Collection of all immediate-onset systemic allergic
reactions will continue for each patient enrolled in the study until the patient
discontinues Plenaxis® for any reason, the patient withdraws consent to continue in the
study or the patient is lost to follow-up.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Estimate the incidence of immediate-onset systemic allergic reactions in the indicated population receiving Plenaxis
Gerald Riedel, PhD
Study Director
PRAECIS Pharmaceuticals Inc.
United States: Food and Drug Administration
149-IV-01
NCT00103623
June 2004
December 2008
Name | Location |
---|---|
Foundation for Cancer Research and Education | Phoenix, Arizona 85013 |
Bryn Mawr Urology | Bryn Mawr, Pennsylvania 19010 |
UroSearch | Leesburg, Florida 34748 |
Atlantic Urological Medical Group | Long Beach, California 90806 |
Kansas City Urology Care | Kansas City, Missouri 64131 |
South Orange County Medical Research Center | Laguna Hills, California 92653 |
Heartland Oncology and Hematology | Council Bluffs, Iowa 51503 |
Northeast Urology Research | Concord, North Carolina 28025 |
Staten Island Urological Research, PC | Staten Island, New York 10304 |
Triangle Urological Group | Pittsburgh, Pennsylvania 15212 |
Carolina Urologic Research Center | Myrtle Beach, South Carolina 29572 |
Millenium Therapeutics & Research - Urology Practice | Birmingham, Alabama 35205 |
Valley Urologic Associates | Goodyear, Arizona 85338 |
Arizona Urologic Specialists | Tucson, Arizona 85712 |
Alfred Sidhom, MD, FACS, PC | Anaheim, California 92801 |
Dr. Chris Threatt | Atherton, California 94027 |
Hematology-Oncology Group of Fresno | Fresno, California 93720 |
Paul Neustein, MD. INC | Poway, California 92064 |
San Diego Urology | San Diego, California 91942 |
Sherman Oaks Urological Medical Group, Inc. | Sherman Oaks, California 91403 |
Urology Associates PC | Denver, Colorado 80210 |
Urologic Associates | Fort Meyers, Florida 33919 |
Southwest Florida Urologic Associates | Fort Myers, Florida 33907 |
University of Florida Shands Jacksonville | Jacksonville, Florida 32209 |
Urology Associates of Ocala, P.A. | Ocala, Florida 34474 |
South Florida Urology Center, Inc. | Pembroke Pines, Florida 33028 |
South Florida Urology Center Inc | Pembroke Pines, Florida 33028 |
Uro-Medix, Inc | Sunrise, Florida 33351 |
Osvaldo F. Padron MD, FACS | Tampa, Florida 33614 |
Urological Surgical Services | Tavares, Florida 32778 |
Osler Medical | West Melbourne, Florida 32901 |
Urology Associates, P.C. | Marietta, Georgia 30060 |
Midwest Prostate Urology Health Center | Chicago, Illinois 60640 |
Praire Medical Associates, LTD | Chicago, Illinois 60616 |
Urology of Indiana | Indianapolis, Indiana 46254 |
Unity HealthCare DBA Lafayette Clinic of Urology | Lafayette, Indiana 47905 |
Private Practice | Emporia, Kansas 66801 |
KUMC Department of Urology | Kansas City, Kansas 66160 |
Tri-County Urology | Milford, Massachusetts 01757 |
Bay State Clinical Trials Inc | Watertown, Massachusetts 02472 |
Tewodros Fresseha MD PC | Southfield, Michigan 48075 |
Lakeside Urology | St. Joseph, Michigan 49085 |
Midwest Urology | Independence, Missouri 64055 |
Quality Clinical Research, LLC | Omaha, Nebraska 68114 |
Sheldon j. Freedman, MD Ltd | Las Vegas, Nevada 89109 |
Essex-Hudson Urology | Bloomfield, New Jersey 07003 |
Hunterdon Urological Associates, PA | Flemington, New Jersey 08822 |
Northwest Urology Associates | Morristown, New Jersey 07960 |
Roseland Surgical Suite | Roseland, New Jersey 07068 |
Urology Healthcare Associates/Rancocas Medical Center | Willingboro, New Jersey 08046 |
University of North Carolina, Chapel Hill | Chapel Hill, North Carolina 27599 |
American Health Research | Charlotte, North Carolina 28207 |
Washington Urological Associates | Washington, North Carolina 27889 |
Columbus Urology Research | Columbus, Ohio 43214 |
Parkhurst Research Organization | Bethany, Oklahoma 73008 |
Dr. Peter Sinaiko | Langhorne, Pennsylvania 19047 |
Urology and Urological Oncology | Philadelphia, Pennsylvania 19141 |
Dr. Greg Echt | Irving, Texas 75062 |
North West Prostate Institute | Seattle, Washington 98133 |
Roger D. Fincher, MD | Spokane, Washington 99202 |