A randomized placebo-controlled trial of the efficacy and tolerability of flexibly dosed Pregabalin in the treatment of cancer-induced bone pain

PFIZER S0 sites310 target enrollmentMarch 15, 2012

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Treatment of moderate to severe chronic bone pain related to metastatic cancer.
Sponsor: PFIZER S
Enrollment: 310
Status: Active, not recruiting
Last Updated: 4 years ago

No summary available.

Registry

who.int

Start Date

March 15, 2012

End Date

May 22, 2012

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

PFIZER S

•1\. Males/Female subjects aged ? 18 years
•2\. Females of childbearing potential must not be lactating, have a negative serum ?\-HCG pregnancy test, be surgically sterile or be practicing an effective form of contraception. Acceptable methods of contraception are as follows:
•a. Hormonal (oral, injectable or transdermal contraceptives).
•b. Barrier method with spermicide.
•c. Intrauterine device (IUD).
•d. Complete abstinence may be considered acceptable, but must first be discussed on a case\-by\-case basis with the Pfizer Medical Director and Pfizer Clinical Monitor prior to any screening tests for the study.
•3\. The patient must have a malignant, solid tumor with that has been diagnosed as having metastasized to bone, and must have moderate to severe pain secondary to the bone metastasis. The patient should also be able to identify a reference site for pain, if possible, or rate their total body pain due to bone metastases if a specific lesion cannot be identified. Radiographic or scintographic confirmation of site of the painful bone metastases is required.
•4\. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects
•of the trial prior to study entry.
•5\. The patient?s mental status is sufficient to complete efficacy and tolerability scales and assessments.

•1\. Participation in previous clinical trials for pregabalin.
•2\. A previous history of intolerance or hypersensitivity to pregabalin, gabapentin or drugs with similar chemical structure.
•3\. Participation in any other studies involving investigational or marketed products, concomitantly or within 30 days prior to screening.
•4\. Illiterate or unable to complete subject\-rated assessment scales.
•5\. The patient has back pain that, in the clinical judgment of the investigator, is related to mechanical or radicular causes.
•6\. The patient who has undergone diagnostic or therapeutic invasive interventions (angiography, biopsy, surgery) less than 15 days prior to study start that would impact their assessment of pain at the reference pain site or area, in the opinion of the
•investigator.
•7\. Methadone, antiepileptic drugs, current gabapentin or pregabalin use, or the initiation of analgesic therapies during the trial.
•8\. The patient has a physical or mental inability to answer question and comply with treatment protocol (such as an inability to swallow tablets or tolerate oral medication, or intractable nausea and vomiting).
•9\. The patient has a history of significant alcohol, analgesic or narcotic substance abuse within 6 months prior to screening as defined by DSM\-IV\-TR criteria.