The Plenaxis® Experience Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00103623
Recruitment Status : Suspended
First Posted : February 14, 2005
Last Update Posted : September 19, 2006
Information provided by:
PRAECIS Pharmaceuticals Inc.

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Plenaxis Phase 4

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  (Clinical Trial)
Enrollment : 2000 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Incidence of Immediate Onset Systemic Allergic Reactions in Patients Treated With Plenaxis®
Study Start Date : June 2004
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Estimate the incidence of immediate-onset systemic allergic reactions in the indicated population receiving Plenaxis

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00103623

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Sponsors and Collaborators
PRAECIS Pharmaceuticals Inc.
Study Director: Gerald Riedel, PhD PRAECIS Pharmaceuticals Inc. Identifier: NCT00103623     History of Changes
Other Study ID Numbers: 149-IV-01
First Posted: February 14, 2005    Key Record Dates
Last Update Posted: September 19, 2006
Last Verified: September 2006

Keywords provided by PRAECIS Pharmaceuticals Inc.:
Advanced Symptomatic Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs