safety and efficacy of gabapentin in diabetic peripheral neuropathy

Conditions: Diabetic Peripheral Neuropathy

Summary: the purpose of this study is to determine whether a new gabapentin tablet, is safe and effective for the treatment of painful diabetic peripheral neuropathy.


Eligibility criteria:
inclusion criteria: * men or women 18 years or older with diagnosis of type 1 or type 2 diabetes who have reported symmetrical painful symptoms in distal extremities for 1-5 years prior to the study and whose symptoms are attributable to sensorimotor diabetic peripheral neuropathy (dpn). * patients of childbearing potential must have a negative urine pregnancy test at screening/randomization, and must use medically acceptable methods of birth control. * patient has pain score of at least 4 on the 11-point likert numerical rating scale at screening. potential patients should not be informed of the pain intensity eligibility criterion prior to screening or randomization. * patient has a mean baseline week pain intensity of at least 4 on the 11-point likert scale at the end of a one-week pre-treatment period and has completed at least 4 days of diary entries during the baseline week. * patient is on stable regimen of antidiabetes medication at screening that can be maintained during the study. * patient has hemoglobin a1c (hba1c) ≤11% at screening. * patient has fpg ≤310 mg/dl at screening. * patient must have a minimum washout of greater than 5 times the half-life of the drug of any of several medications * patients currently treated with gabapentin or pregabalin at screening may be eligible for the study, but must have tapering period wherein the dose of gabapentin is reduced gradually over a period of at least 7 days plus a 2-day or 3-day washout of gabapentin or pregabalin, respectively, prior to start of the baseline week. * patient must have adequate eyesight to complete questions on the diarypro and sitepro. if a patient is unable to do so (for reasons other than severe eye disease) but a caregiver is available to complete these tasks following instruction from the patient, the caregiver may be trained to accomplish these tasks exclusion criteria: * patients who have previously not responded to treatment for dpn with gabapentin at doses of ≥1200 mg/day or pregabalin at doses ≥300 mg/day. * patients who previously experienced dose-limiting adverse effects that prevented titration of gabapentin to an effective dose. * patient has hypersensitivity to gabapentin. * patient is a nursing mother. * patient has used injected anesthetics or steroids within 30 days of baseline. * patient has certain conditions that could confound evaluation of painful dpn, in particular, amputations other than toes, non-diabetic neurologic disorders (e.g. phantom limb pain), and skin conditions affecting sensation in painful limbs. * patient has skin conditions in the area affected by the neuropathy that could alter sensation. * patient is in an immunocompromised state. * patient has an estimated creatinine clearance of \<60 ml/min calculated using the cockroft gault method (appendix 3). * patient has had malignancy within past 2 years other than basal cell carcinoma. * patient has had gastric reduction surgery. * patient has severe chronic diarrhea, chronic constipation \[unless attributed to drugs that will be washed out\], uncontrolled irritable bowel syndrome (ibs) or unexplained weight loss. * patient has any abnormal chemistry or hematology results that are deemed by the investigator to be clinically significant. * patient has a history of substance abuse within the past year. * patient has had 1 or more visits to an emergency room or hospital within the previous 30 days due to hypoglycemia. * patient has a history of seizure (except for infantile febrile seizure) or is at risk of seizure due to head trauma. * patient has a history of pernicious anemia, untreated hypothyroidism, chronic hepatitis b or c, hepatitis within the past 3 months, or hiv infection. * patient has any other serious medical condition that, in the opinion of the investigator would jeopardize the safety of the patient or affect the validity of the study results. * continuing use of any concomitant medication excluded by inclusion criterion 8. * patient has participated in a clinical trial of an investigational drug or device within 30 days of the screening visit

Keywords: dpn, diabetic peripheral neuropathy painful