The Plenaxis® Experience Study

September 18, 2006 updated by: PRAECIS Pharmaceuticals Inc.

Incidence of Immediate Onset Systemic Allergic Reactions in Patients Treated With Plenaxis®

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

2000

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Millenium Therapeutics & Research - Urology Practice
    • Arizona
      • Goodyear, Arizona, United States, 85338
        • Valley Urologic Associates
      • Phoenix, Arizona, United States, 85013
        • Foundation for Cancer Research and Education
      • Tucson, Arizona, United States, 85712
        • Arizona Urologic Specialists
    • California
      • Anaheim, California, United States, 92801
        • Alfred Sidhom, MD, FACS, PC
      • Atherton, California, United States, 94027
        • Dr. Chris Threatt
      • Fresno, California, United States, 93720
        • Hematology-Oncology Group of Fresno
      • Laguna Woods, California, United States, 92653
        • South Orange County Medical Research Center
      • Long Beach, California, United States, 90806
        • Atlantic Urological Medical Group
      • Poway, California, United States, 92064
        • Paul Neustein, MD. INC
      • San Diego, California, United States, 91942
        • San Diego Urology
      • Sherman Oaks, California, United States, 91403
        • Sherman Oaks Urological Medical Group, Inc.
    • Colorado
      • Denver, Colorado, United States, 80210
        • Urology Associates PC
    • Florida
      • Fort Meyers, Florida, United States, 33919
        • Urologic Associates
      • Fort Myers, Florida, United States, 33907
        • Southwest Florida Urologic Associates
      • Jacksonville, Florida, United States, 32209
        • University of Florida Shands Jacksonville
      • Ocala, Florida, United States, 34470
        • UroSearch
      • Ocala, Florida, United States, 34474
        • Urology Associates of Ocala, P.A.
      • Pembroke Pines, Florida, United States, 33028
        • South Florida Urology Center Inc
      • Pembroke Pines, Florida, United States, 33028
        • South Florida Urology Center, Inc.
      • Sunrise, Florida, United States, 33351
        • Uro-Medix, Inc
      • Tampa, Florida, United States, 33614
        • Osvaldo F. Padron MD, FACS
      • Tavares, Florida, United States, 32778
        • Urological Surgical Services
      • West Melbourne, Florida, United States, 32901
        • Osler Medical
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Urology Associates, P.C.
    • Illinois
      • Chicago, Illinois, United States, 60616
        • Praire Medical Associates, LTD
      • Chicago, Illinois, United States, 60640
        • Midwest Prostate Urology Health Center
    • Indiana
      • Indianapolis, Indiana, United States, 46254
        • Urology of Indiana
      • Lafayette, Indiana, United States, 47905
        • Unity HealthCare DBA Lafayette Clinic of Urology
    • Iowa
      • Council Bluffs, Iowa, United States, 51503
        • Heartland Oncology and Hematology
    • Kansas
      • Emporia, Kansas, United States, 66801
        • Private Practice
      • Kansas City, Kansas, United States, 66160
        • KUMC Department of Urology
    • Massachusetts
      • Milford, Massachusetts, United States, 01757
        • Tri-County Urology
      • Watertown, Massachusetts, United States, 02472
        • Bay State Clinical Trials Inc
    • Michigan
      • Southfield, Michigan, United States, 48075
        • Tewodros Fresseha MD PC
      • St. Joseph, Michigan, United States, 49085
        • Lakeside Urology
    • Missouri
      • Independence, Missouri, United States, 64055
        • Midwest Urology
      • Kansas City, Missouri, United States, 64131
        • Kansas City Urology Care
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Quality Clinical Research, LLC
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Sheldon j. Freedman, MD Ltd
    • New Jersey
      • Bloomfield, New Jersey, United States, 07003
        • Essex-Hudson Urology
      • Flemington, New Jersey, United States, 08822
        • Hunterdon Urological Associates, PA
      • Morristown, New Jersey, United States, 07960
        • Northwest Urology Associates
      • Roseland, New Jersey, United States, 07068
        • Roseland Surgical Suite
      • Willingboro, New Jersey, United States, 08046
        • Urology Healthcare Associates/Rancocas Medical Center
    • New York
      • Staten Island, New York, United States, 10304
        • Staten Island Urological Research, PC
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina, Chapel Hill
      • Charlotte, North Carolina, United States, 28207
        • American Health Research
      • Concord, North Carolina, United States, 28025
        • Northeast Urology Research
      • Washington, North Carolina, United States, 27889
        • Washington Urological Associates
    • Ohio
      • Columbus, Ohio, United States, 43214
        • Columbus Urology Research
    • Oklahoma
      • Bethany, Oklahoma, United States, 73008
        • Parkhurst Research Organization
    • Pennsylvania
      • Devon, Pennsylvania, United States, 19333
        • Bryn Mawr Urology
      • Langhorne, Pennsylvania, United States, 19047
        • Dr. Peter Sinaiko
      • Philadelphia, Pennsylvania, United States, 19141
        • Urology and Urological Oncology
      • Pittsburgh, Pennsylvania, United States, 15212
        • Triangle Urological Group
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Carolina Urologic Research Center
    • Texas
      • Irving, Texas, United States, 75062
        • Dr. Greg Echt
    • Washington
      • Seattle, Washington, United States, 98133
        • North West Prostate Institute
      • Spokane, Washington, United States, 99202
        • Roger D. Fincher, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

A subject is eligible to participate in the study if he meets the following criteria:

  • Male ≥ 18 years old with advanced symptomatic prostate cancer for whom LHRH agonist therapy is not appropriate and who refuses surgical castration

  • Has at least one of the following:

    1. Risk of neurological compromise due to metastases,
    2. Ureteral or bladder outlet obstruction due to local encroachment or metastatic disease or
    3. Severe bone pain from skeletal metastases persisting on narcotic analgesia
  • Patients or their legal representatives must be able to read, understand and sign an informed consent form to participate in the trial.

Exclusion Criteria:

  • Female Patients,
  • Pediatric patients,
  • Patients with known hypersensitivity to any of the components in the abarelix injectable suspension

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Estimate the incidence of immediate-onset systemic allergic reactions in the indicated population receiving Plenaxis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PRAECIS Pharmaceuticals Inc.

Investigators

  • Study Director: Gerald Riedel, PhD, PRAECIS Pharmaceuticals Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Study Completion

December 1, 2008

Study Registration Dates

First Submitted

February 11, 2005

First Submitted That Met QC Criteria

February 11, 2005

First Posted (Estimate)

February 14, 2005

Study Record Updates

Last Update Posted (Estimate)

September 19, 2006

Last Update Submitted That Met QC Criteria

September 18, 2006

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 149-IV-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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