PER-067-09
Completed
未知
A Randomized Placebo-Controlled Trial Of The Efficacy And Tolerability Of Flexibly Dosed Pregabalin In The Treatment Of Cancer-Induced Bone Pain
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- PFIZER S.A.,
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
- •Males/Female subjects aged \=18 years
- •Females of childbearing potential must not be lactating, have a negative serum ß\-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.
- •The subject must have a malignant, solid tumor that has been diagnosed as having metastasized to bone. The patient must be able to identify a reference site for pain. Radiographic or scintographic confirmation of site of the painful bone metastases (obtained within 60 days of screening) is required.
- •The subject’s mental status is sufficient to complete efficacy and tolerability scales and assessments.
- •Subject is willing and able to comply with scheduled visits, treatment plan, screening laboratory tests and other trial procedures.
- •Subject must have a daily worst pain at the reference site score of at least 4 on an 11\- point anchored scale at Screening (Visit 1\).
- •The subject has a performance status score of 0\-2 (inclusive) as measured by the ECOG.
- •Life expectancy \=3 months from start of the study
- •Creatinine Clearance \=30 mL/min as calculated by the Cockcroft\-Gault equation.
Exclusion Criteria
- •Participation in previous clinical trials for Pregabalin.
- •A previous history of intolerance or hypersensitivity to Pregabalin, Gabapentin or drugs with similar chemical structure.
- •Participation in any other studies involving investigational or marketed products, concomitantly or within 30 days prior to screening.
- •Illiterate or unable to complete subject\-rated assessment scales.
- •The subject has back pain that, in the clinical judgment of the investigator, is related to mechanical or radicular causes.
- •The subject 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.
- •Use of antiepileptic drugs, current Gabapentin or Pregabalin use, or the initiation of disallowed analgesic and other therapies during the trial.
- •The subject is physically, psychologically, or mentally unable to comply with treatment protocol (such as an inability to swallow tablets or tolerate oral medication, or intractable nausea and vomiting) or perform study procedures.
- •The subject has a history of significant alcohol, analgesic or narcotic substance abuse within 6 months prior to screening as defined by DSM\-IV\-TR® criteria.
- •The subject has a known current seizure disorder.
Outcomes
Primary Outcomes
Not specified
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