Diabetic Peripheral Neuropathic Pain (DPNP)

Launched by BRISTOL-MYERS SQUIBB · Mar 11, 2011

Keywords

ClinConnect Summary

Allocation: Randomized Stratified; Intervention Model: Cross-over Versus Comparator + Placebo

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Type I or Type II diabetes with painful, distal, symmetrical, sensory-motor neuropathy attributed to diabetes, of at least 6 months duration.
• • Score of ≥3 on Michigan Neuropathy Screening Instrument
• • The patient is able to satisfactorily complete, in the Investigator's judgment, the Cognitive Battery.
• • Based on patient diary information collected during the Screening/Baseline period, the patient has completed at least 5 of 7 daily diary entries and has an average weekly pain rating of at least 4 on the 11-point pain rating scale, in the week immediately prior to randomization (Baseline Visit).
• • Male or female, 18-85 years of age.
• Exclusion Criteria:
• • History of complete lack of response to Pregabalin (at least 300 mg qd for 4 weeks) or Gabapentin (at least 1800 mg qd for 4 weeks).
• • Other severe pain that may potentially confound pain assessment.
• • Hemoglobin A1c \> 9%
• • Hemoglobin ≤ 9 g/dL
• • Estimated glomerular filtration rate (eGFR) according to the re-expressed abbreviated (four-variable) Modification of Diet in Renal Disease (MDRD) Study equation ≤ 50ml/min/1.73m2
• • Patients who have been on a stable dose of anticonvulsant, anticholinergic, diabetic meds, nicotine replacements, or any other smoking cessation meds for \<4 weeks prior to randomization. Patients who are on stable doses for ≥ 4 weeks prior to randomization are allowed, however, there should be no adjustments to the dose of these medications during study.
• • Patients currently on more than one drug for treatment of neuropathic pain (low dose opioids or antidepressants). Patients are allowed to participate if on a stable dose of for at least 4 weeks prior to randomization (Day1) and should remain stable during study.