Evaluation of the Impact of Training on Outcome Measures in Subjects With Painful Diabetic Neuropathy

• Diabetes Mellitus
• Painful Distal Symmetric Sensorimotor Polyneuropathy

• Drug: Pregabalin
• Drug: placebo
• Behavioral: Training Type A
• Behavioral: Training Type B

• Training Type A, pregabalin
  Subjects randomized to receive pregabalin at a site that received training Type A
  Interventions:

  • Drug: Pregabalin
  • Behavioral: Training Type A
• Training Type B, pregabalin
  Subjects randomized to receive pregabalin at a site that received training Type B
  Interventions:

  • Drug: Pregabalin
  • Behavioral: Training Type B
• Training Type A, placebo
  Subjects randomized to receive placebo at a site that received training Type A
  Interventions:

  • Drug: placebo
  • Behavioral: Training Type A
• Training Type B, placebo
  Subjects randomized to receive placebo at a site that received training Type B
  Interventions:

  • Drug: placebo
  • Behavioral: Training Type B

Inclusion Criteria:

• Willingly signs and dates an Informed Consent Form (ICF) that is approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC), prior to the conduct of any study-specific procedures;
• Is at least 18 years old;
• Has a diagnosis of type 1 or type 2 diabetes and painful distal symmetric sensorimotor polyneuropathy;
• Has experienced a minimum duration of PDN of at least 6 months;
• Is on stable diabetic medication that is not expected to change during the study;
• Has a worst pain intensity over the past 24 hours as a 4 or higher on a 0-10 numerical rating scale at Screening;
• And is able to read and communicate meaningfully in English and comply with all study procedures

Exclusion Criteria:

• Has a psychiatric or psychological disorder that in the judgment of the Investigator would interfere with the completion of the study, confound the study results, or pose subject risk;
• Has an uncontrolled, clinically significant medical condition that in the judgment of the Investigator may contraindicate use of pregabalin or participation in the study (e.g., hepatic, respiratory, or hematologic illness; cardiovascular disease; or symptomatic peripheral vascular disease);
• Has experience as an investigator or a study staff member in clinical trials research in a role that involved direct patient contact;
• Participated in any of the following studies: Analgesic Solutions Protocol # ALPMF.SOW.0007, Analgesic Solutions Protocol # ALPMF.SOW.0007.02, or Astellas Protocol # E05-CL-3004;
• Has pain of other origin that might confound assessment of PDN;
• Has major skin ulceration;
• Has had an amputation other than toes;
• Has a history of suicide attempt within the past 1 year;
• Reports current suicidal ideation within the past 1month;
• Has history of kidney disease that is likely to decrease creatinine clearance;
• Has creatinine clearance below 60 as calculated by Cockroft-Gault equation for serum creatinine;
• Has a history of drug or alcohol abuse within the past 1 year;
• Has hypersensitivity, intolerance, or allergy to pregabalin or gabapentin;
• Subject is pregnant, is considering becoming pregnant during the study, is breastfeeding or unwilling to use adequate birth control during the study;
• Participated in another clinical trial within the past month;
• Is involved in an ongoing or settled worker's compensation claim, disability, or litigation;
• Has a known failure to respond to pregabalin or gabapentin at a clinically relevant dose due to either efficacy or tolerability;
• Or has taken opioids on an as-needed basis within 1week of Screening, or has taken pregabalin or gabapentin within 30 days of screening. Subjects on stable doses opioids, antidepressants, non-steroidal anti-inflammatory drugs, or low-dose aspirin will be allowed to participate in the study

• Astellas Pharma Europe B.V.
• Pfizer