The Plenaxis® Experience Study
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: Plenaxis |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Incidence of Immediate Onset Systemic Allergic Reactions in Patients Treated With Plenaxis® |
- Estimate the incidence of immediate-onset systemic allergic reactions in the indicated population receiving Plenaxis
| Estimated Enrollment: | 2000 |
| Study Start Date: | June 2004 |
| Estimated Study Completion Date: | December 2008 |
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| Ages Eligible for Study: | 18 Years and older |
| Genders 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:
- Risk of neurological compromise due to metastases,
- Ureteral or bladder outlet obstruction due to local encroachment or metastatic disease or
- 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
Contacts and Locations
Show 60 Study Locations| Study Director: | Gerald Riedel, PhD | PRAECIS Pharmaceuticals Inc. |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00103623 History of Changes |
| Other Study ID Numbers: | 149-IV-01 |
| Study First Received: | February 11, 2005 |
| Last Updated: | September 18, 2006 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by PRAECIS Pharmaceuticals Inc.:
|
Advanced Symptomatic Prostate Cancer Advanced Symptomatic Prostate Cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male |
Prostatic Diseases Abarelix Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013