The Plenaxis® Experience Study - Full Text View

Sponsor:	PRAECIS Pharmaceuticals Inc.
Information provided by:	PRAECIS Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:	NCT00103623

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®

Resource links provided by NLM:

MedlinePlus related topics: Allergy Cancer Prostate Cancer

U.S. FDA Resources

Further study details as provided by PRAECIS Pharmaceuticals Inc.:

Primary Outcome Measures:

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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00103623

Show 60 Study Locations

Sponsors and Collaborators

PRAECIS Pharmaceuticals Inc.

Investigators

Study Director:

Gerald Riedel, PhD

PRAECIS PHARMACEUTICALS

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 May 24, 2012