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The Plenaxis® Experience Study

This study has suspended participant recruitment.
Sponsor:
Information provided by:
PRAECIS Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT00103623
First received: February 11, 2005
Last updated: September 18, 2006
Last verified: September 2006

February 11, 2005
September 18, 2006
June 2004
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Estimate the incidence of immediate-onset systemic allergic reactions in the indicated population receiving Plenaxis
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Complete list of historical versions of study NCT00103623 on ClinicalTrials.gov Archive Site
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The Plenaxis® Experience Study
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.

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
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
Drug: Plenaxis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
2000
December 2008
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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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00103623
149-IV-01
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PRAECIS Pharmaceuticals Inc.
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Study Director: Gerald Riedel, PhD PRAECIS Pharmaceuticals Inc.
PRAECIS Pharmaceuticals Inc.
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP