A RANDOMIZED PLACEBO-CONTROLLED TRIAL OF THE EFFICACY AND TOLERABILITY OF FLEXIBLY DOSED PREGABALIN IN THE TREATMENT OF CANCER-INDUCED BONE PAIN. - NA

• Conditions: Treatment of moderate to severe chronic bone pain related to metastatic cancer.; MedDRA version: 8.1Level: LLTClassification code 10049038Term: Metastatic bone pain

• Registration Number: EUCTR2006-002486-39-CZ
• Lead Sponsor: Pfizer Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12-10
• Last Update Posted: 29 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 310

Inclusion Criteria

Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
1. 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.
2. Males/Female subjects aged =18 years
3. 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.
4. 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.
5. The subject’s mental status is sufficient to complete efficacy and tolerability scales and assessments.
6. Subject is willing and able to comply with scheduled visits, treatment plan, screening laboratory tests and other trial procedures.
7. 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).
8. The subject has a performance status score of 0-2 (inclusive) as measured by the ECOG.
9. Life expectancy =3 months from start of the study
10. Creatinine Clearance =30 mL/min as calculated by the Cockcroft-Gault equation.
11. Total white blood cell count >1500 per cubic millimeter; platelet count =50 x103 per cubic millimeter.
12. If applicable, stable (initiated = one month prior to Screening) chemotherapy treatment, and no initiation of new chemotherapy regimen planned over course of the study.
13. If applicable, radiotherapy or radiopharmaceutical treatment to the target lesion initiated =15 days prior to Screening, and no initiation of new therapy planned to target lesion over course of study.
14. If applicable, stable bisphosphonate therapy (ie, initiated more than two months prior to Screening) and no new bisphonsponate therapy planned over course of study.
15. Subject must have an average ‘Daily Worst Pain’ score of =4 at the reference site (as recorded in the daily diary) in the week preceding randomization (minimum 4 data points); and
16. Subject must be treated with opioid therapy such that he/she takes a constant daily dose of opioid (SR or IR), with =4 doses IR opioid per day allowed as rescue medication in the week preceding randomization; and
17. Subject must not be experiencing intolerable side effects from the total daily dose of opioids (eg, dose limiting side effects in the opinion of the patient and/or investigator).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects presenting with any of the following are not to be included in the trial:
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 subject has back pain that, in the clinical judgment of the investigator, is related to mechanical or radicular causes.
6. 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.
7. Use of antiepileptic drugs, current Gabapentin or Pregabalin use, or the initiation of disallowed analgesic and other therapies during the trial.
8. 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.
9. 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.
10. The subject has a known current seizure disorder.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified