Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

Launched by DAIICHI SANKYO · Dec 20, 2011

Keywords

ClinConnect Summary

Diabetic peripheral neuropathy (DPN) affects up to 50% of patients who have diabetes for at least 25 years. Up to 26% of all patients with DPN experience neuropathic pain. DPN pain contributes to sleep disorders, depression, and anxiety, which together may have an impact on a patient's well-being and quality of life.

There are currently several drugs used to treat painful DPN. For example, Lyrica® (pregabalin) is approved by the United States Food and Drug Administration (FDA) to treat neuropathic pain associated with DPN and is commonly prescribed. The dosage of the FDA-approved drugs is ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age \> 18 years of age
• • 2. Able to give informed consent and willing to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures
• • 3. Type 1 or type 2 diabetes with a hemoglobin A1c (HbA1c) ≤ 10% at Screening and on a stable antidiabetic medication regimen for at least 30 days prior to Screening (insulin therapy is acceptable)
• • 4. Painful distal symmetrical sensorimotor polyneuropathy (as per American Society of Pain Educators guidelines ) diagnosed for at least 6 months, based on neurological history and/or examination; diagnosis includes absent or reduced deep tendon reflexes at both ankles
• • 5. At Screening, a pain score of ≥ 40 mm on the SF-MPQ VAS
• • 6. At Randomization, a pain score of ≥ 40 mm on the SF-MPQ VAS and an ADPS of ≥ 4 on the 11-point NRS, the latter calculated from a minimum of 4 pain ratings in daily diaries obtained during the 1-week Baseline Period (prior to randomization)
• • 7. Creatinine clearance \> 60 mL/min (estimated using the Cockcroft-Gault equation)
• • 8. Antidiabetic and other medications anticipated to remain stable and constant during the study period
• • 9. Women of child bearing potential (WOCBP) must be using an adequate method of contraception as detailed in the protocol to avoid pregnancy during the study and for 4 weeks after study completion
• Exclusion Criteria:
• • 1. Diagnosis of mononeuropathy
• • 2. Use of concomitant medications that may confound assessments of efficacy and/or safety (see Section 5.2)
• • 3. Major psychiatric disorders
• • 4. Have had a malignancy other than basal cell carcinoma within the past 2 years
• • 5. At Visit 1, have a white blood cell count \< 2500/mm3, neutrophil count \< 1500/mm3, or platelet count \< 100 x 103/mm3
• • 6. Clinically significant unstable diabetes mellitus, unstable hepatic, respiratory, or hematologic illness, unstable cardiovascular disease (including myocardial infarction in the 3 months prior to Visit 1), or symptomatic peripheral vascular disease
• • 7. Clinically significant findings on the Screening ECG
• • 8. History of pernicious anemia, untreated hypothyroidism, chronic hepatitis B, hepatitis B within the past 3 months, or human immunodeficiency virus infection
• • 9. Amputations of body parts other than toes
• • 10. Prior therapeutic failure of pregabalin or gabapentin (considered unresponsive or intolerant to treatment); therapeutic failure implies lack of efficacy following full titration to effective doses (eg, 300 mg/day for pregabalin)
• • 11. Known hypersensitivity to pregabalin or gabapentin
• • 12. Requirement for concomitant anticonvulsant and antidepressant therapy, with the exception of stable doses of SSRIs
• • 13. Neurologic disorders unrelated to DPN that may confound the assessment of pain associated with DPN
• • 14. Skin conditions that could alter sensation
• • 15. Other sources of pain that may confound assessment or self-evaluation of the pain due to DPN
• • 16. Abuse of prescription medications, street drugs or alcohol (including alcohol dependence) within the last 1 year
• • 17. Current enrollment in another investigational study, participation in another investigational study with the past 30 days, or other current or recent use of any investigational drug
• • 18. Pregnancy (as based on lab test results) or breast feeding
• • 19. Laboratory values exceeding limits listed in Table 4.1 of the protocol