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

Status

Indicates the current recruitment status or the expanded access status.
Suspended

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
PRAECIS Pharmaceuticals Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2004

Study Completion

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 11, 2005

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2005

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 14, 2005

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 19, 2006

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2006

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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