Spots Global Cancer Trial Database for The Plenaxis® Experience Study
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Trial Identification
Brief Title: The Plenaxis® Experience Study
Official Title: Incidence of Immediate Onset Systemic Allergic Reactions in Patients Treated With Plenaxis®
Study ID: NCT00103623
Conditions
Interventions
Study Description
Brief Summary: Praecis is currently conducting a 2000 patient Experience Study; this is a Phase IV commitment postmarketing safety study in the Food and Drug Administration (FDA) indicated population of patients receiving Plenaxis®. The purpose of the study is to estimate the incidence of immediate-onset systemic allergic reactions in the indicated population receiving Plenaxis® and to determine whether the hazard rate changes over time.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Millenium Therapeutics & Research - Urology Practice, Birmingham, Alabama, United States
Valley Urologic Associates, Goodyear, Arizona, United States
Foundation for Cancer Research and Education, Phoenix, Arizona, United States
Arizona Urologic Specialists, Tucson, Arizona, United States
Alfred Sidhom, MD, FACS, PC, Anaheim, California, United States
Dr. Chris Threatt, Atherton, California, United States
Hematology-Oncology Group of Fresno, Fresno, California, United States
South Orange County Medical Research Center, Laguna Woods, California, United States
Atlantic Urological Medical Group, Long Beach, California, United States
Paul Neustein, MD. INC, Poway, California, United States
San Diego Urology, San Diego, California, United States
Sherman Oaks Urological Medical Group, Inc., Sherman Oaks, California, United States
Urology Associates PC, Denver, Colorado, United States
Urologic Associates, Fort Meyers, Florida, United States
Southwest Florida Urologic Associates, Fort Myers, Florida, United States
University of Florida Shands Jacksonville, Jacksonville, Florida, United States
UroSearch, Ocala, Florida, United States
Urology Associates of Ocala, P.A., Ocala, Florida, United States
South Florida Urology Center Inc, Pembroke Pines, Florida, United States
South Florida Urology Center, Inc., Pembroke Pines, Florida, United States
Uro-Medix, Inc, Sunrise, Florida, United States
Osvaldo F. Padron MD, FACS, Tampa, Florida, United States
Urological Surgical Services, Tavares, Florida, United States
Osler Medical, West Melbourne, Florida, United States
Urology Associates, P.C., Marietta, Georgia, United States
Praire Medical Associates, LTD, Chicago, Illinois, United States
Midwest Prostate Urology Health Center, Chicago, Illinois, United States
Urology of Indiana, Indianapolis, Indiana, United States
Unity HealthCare DBA Lafayette Clinic of Urology, Lafayette, Indiana, United States
Heartland Oncology and Hematology, Council Bluffs, Iowa, United States
Private Practice, Emporia, Kansas, United States
KUMC Department of Urology, Kansas City, Kansas, United States
Tri-County Urology, Milford, Massachusetts, United States
Bay State Clinical Trials Inc, Watertown, Massachusetts, United States
Tewodros Fresseha MD PC, Southfield, Michigan, United States
Lakeside Urology, St. Joseph, Michigan, United States
Midwest Urology, Independence, Missouri, United States
Kansas City Urology Care, Kansas City, Missouri, United States
Quality Clinical Research, LLC, Omaha, Nebraska, United States
Sheldon j. Freedman, MD Ltd, Las Vegas, Nevada, United States
Essex-Hudson Urology, Bloomfield, New Jersey, United States
Hunterdon Urological Associates, PA, Flemington, New Jersey, United States
Northwest Urology Associates, Morristown, New Jersey, United States
Roseland Surgical Suite, Roseland, New Jersey, United States
Urology Healthcare Associates/Rancocas Medical Center, Willingboro, New Jersey, United States
Staten Island Urological Research, PC, Staten Island, New York, United States
University of North Carolina, Chapel Hill, Chapel Hill, North Carolina, United States
American Health Research, Charlotte, North Carolina, United States
Northeast Urology Research, Concord, North Carolina, United States
Washington Urological Associates, Washington, North Carolina, United States
Columbus Urology Research, Columbus, Ohio, United States
Parkhurst Research Organization, Bethany, Oklahoma, United States
Bryn Mawr Urology, Devon, Pennsylvania, United States
Dr. Peter Sinaiko, Langhorne, Pennsylvania, United States
Urology and Urological Oncology, Philadelphia, Pennsylvania, United States
Triangle Urological Group, Pittsburgh, Pennsylvania, United States
Carolina Urologic Research Center, Myrtle Beach, South Carolina, United States
Dr. Greg Echt, Irving, Texas, United States
North West Prostate Institute, Seattle, Washington, United States
Roger D. Fincher, MD, Spokane, Washington, United States
Contact Details
Name: Gerald Riedel, PhD
Affiliation: PRAECIS Pharmaceuticals Inc.
Role: STUDY_DIRECTOR
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