PER-089-06已完成未知
A Prospective, Open Label, Multi-Center, Study Of Pregabalin In The Treatment Of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy, Postherpetic Neuralgia, HIV-Related Peripheral Neuropathic Pain And Chemotherapy Induced Peripheral Neuropathic Pain
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- PFIZER S.A.,
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 0（—）
入选标准
- •1. Patients who are diagnosed of neuropathic pain associated with DPN, PHN, HIV-PNP or C-PNP.
- •2. Male or female patients of any ethnic origin aged 18 years or over.
- •3. Outpatients status.
- •4. Women of childbearing potential must have a negativo urine B-HCG pregnancy test and be practicing an effective form of contraception.
- •5. Patients taking pharmacological therapies for neurophatic pain must be stabilized > 30 days prior to screening, and be willing to held them constant and avoid change or initiation of new therapies throughout the course of the trial.
- •6. Patients undergoing stable non-pharmacological therapies for neuropathic pain, if used in normal routine > 30 days prior to screening, must be willing to held them constant and avoid change or initiation of new therapies throughout the course of the trial.
- •7. Evidence of a personally signed informed consent document indicating that the subject has been informed of all pertinent aspects of the trial.
- •8. Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
- •9. Score of ≥ 40 mm on the 100-mm Visual Analogue Scale (VAS) at screening.
- •10. Must have completed at least 4 consecutive daily pain diaries (DPRS) during the 7 days prior to trial drug treatment.
- •11. Daily diary average pain score of ≥ 4 over the 7 days prior to trial drug treatment based on Daily Pain Rating Scale (DPRS).
- •12. Score of ≥ 4/10 on the neuropathic pain diagnostic questionnaire (DN4)
- •Inclusion criteria applied to patients with PHN:
- •13. Pain present for > 3 months after healing of herpes zoster skin rash.
- •14. Screening laboratory values must be within normal limits, or abnormalities must be clinically insignificant.
- •Inclusion criteria applied to patients with HIV-PNP:
- •15. Patients with confirmed diagnosis of HIV infection.
- •16. HIV-associated neuropathic pain present for at least 3 months prior to trial start.
- •17. Patients on stable HIV and pain medications.
- •Inclusion criteria applied to patients with C-PNP:
- •18. Chemotherapy induced neuropathic pain present for at least 3 months prior to trial start.
- •19. Patients must have had their last dose of radiation therapy at least 4 weeks prior to trial entry.
- •20. Patients must have their last dose of chemotherapy and/or their last dose of any investigational cancer therapy at least 4 weeks prior to trial entry.
- •21. Patients must have recovered from the toxic effects of all prior therapy before entry onto this trial.
- •22. Patients with brain tumors must be on a stable or tapering dose of corticosteroids for 7 days prior to the baseline sean performed for the purpose of assessing response to therapy on this trial.
排除标准
- •1. Severe pain associated with conditions other than DPN, PHN, HIV-PNP and C-PNP that may confound assessment or self-evaluation of the neuropathic pain.
- •2. Skin conditions in the affected dermatome that could alter sensation.
- •3. Primary pain diagnosis of acute lumbosacral radiculopathy / sciatica, chronic low back pain or cervical radiculopathy.
- •4. Clinically significant or unstable medical condition.
- •5. Clinically significant or unstable psychological condition.
- •6. Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the trial and/or evidence of an uncooperative attitude.
- •7. Any moderate to severe autonomic dysfunction.
- •8. Clinically significant abnormal 12-lead ECG.
- •9. Creatinine clearence ≤ 60 mL/min.
- •10. White Blood Cells < 2500/mm3; neutrophil count <1500/mm3; platelet count <100 x l0-9/mm3.
- •11. Liver function tests > 3 times the upper limit of normal.
- •12. A history of illicit drug or alcohol abuse in the past 1 year.
- •13. Current use of illicit drugs.
- •14. Likelihood of requiring treatment during the trial period with drugs not permitted by the protocol.
- •15. Receiving concomitant transcutaneous electrical nerve stimulation or acupuncture.
- •16. A previous history of intolerance or hypersensitivity to the pregabalin, gabapentin or drugs with similar chemical structure.
- •17. Donation of blood/blood products during the 30 days prior to initiation of treatment.
- •18. Participation in a previous pregabalin clinical trial.
- •19. Participation in any other studies involving investigational or marketed products, concomitantly or within 30 days prior to entry in the trial.
- •20. The patient may require hospitalization for any reason.
- •21. Illiterate or unable to answer patient administered assessment scales.
- •22. Any other condition, which increases the risk to the patient or decreasesthe chance of obtaining satisfactory data to achieve the objectives of the trial.
- •23. Neurologic disorders unrelated to the primary diagnosis that may confuse the assessment of neuropathic pain.
- •24. History of pernicious anemia, untreated hypothyroidism, active and chronic hepatitis B or C, hepatitis B or C within the past 3 months.
- •25. Other significant infectious condition diagnosed within the past 3 months.
- •26. Amputations other than toes resulting from a primary clinical condition being investigated.
- •Exclusion criteria applied to DPN patients:
- •27. Neurological disorders unrelated to diabetic neuropathy.
- •28. Presence of severe pain associated with conditions other than diabetic peripheral neuropathy.
- •Exclusion criteria applied to PHN patients:
- •29. History of neurolytic or neurosurgical therapy for PHN.
- •30. Presence of any severe pain associated with conditions other than PHN.
- •31. Known coexistent source of painful peripheral neuropathy or other systemic disease associated with a secondary painful neuropathy.
- •Exclusion criteria applied to HIV-PNP patients:
- •32. Patients on anti-diabetic medications.
- •33. Use of neuroregenerative agents or neurotoxic chemotherapeutic agents by 3 months prior to trial start.
- •34. Use of neurotoxic drugs within 1 month prior to trial start.
- •35. Pulmonary disease of sufficient severity to require the use of supplemental oxygen.
- •36. Life expectancy less than 6 weeks or an active, acute illness likely to interfere with completion o
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