A Phase 3b Multicenter, Double-Blind, Randomized, Placebo-Controlled Cross-Over Efficacy and Safety of Pregabalin in the Treatment of Patients with Painful Diabetic Peripheral Neuropathy and Pain on Walking. Print E-mail

Protocol : A0081269


  1. Evidence of personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
  2. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures including the training and completion of the daily pain and sleep diaries using the IVRS system;
  3. Men or women who are at least 18 years of age.
  4. Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 28 days after the last dose of assigned treatment. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.
  5. Diagnosis of type 1 or 2 diabetes mellitus with current hemoglobin A1c levels of ≤11%. If the subject is on an antidiabetic medication regimen, it must be stable for the 30 days prior to  Visit 2/Randomization;
  6. Diagnosis of painful, diabetic distal symmetrical sensorimotor, polyneuropathy for at least 3months;
  7. Ability to walk 50 feet (15.2m) on a flat surface unassisted.
  8. Meet the following 2 criteria demonstrating inadequate pain control:
    • At visit 1, Screening, a score of ≥4 on the one-week recall, 0-10 point numerical rating scale (Weekly-pain NRS).
    • At visit2/Randomization, subjects must have completed at least 4 daily pain diaries over the past 7 days(baseline) and have an average daily DPN pain score of ≥4 on the 0-10 point numeric rating scale (daily pain diary).

     9.  Meet all of the following criteria demonstrating pain on walking after the walk test.

The walk test will consist of walking 50 feet( 15.2 m) on a flat surface with one turn allowed, ie, 25 feet in one direction and then return), and then immediate completion of the DPN pain on walking NRS:

    • A post-walk pain score of at least 4 or greater, at both V1/ Screening and V2/Randomization.
    • The post-walk pain score at both V1/ Screening and V2/ Randomization.


  1. Have failed pregabalin treatment due to lack of efficacy at therapeutic doses, have intolerance to pregabalin or any pregabalin ingredient, or participated in a pregabalin clinical trial. If the subject has taken pregabalin and discontinued for reasons other than lack of efficacy or intolerance, then they will be eligible. Pregabalin use within the last 30 days (prior to V1) is not permitted;
  2. A pain fluctuation of more than a 4 point difference from the highest to the lowest score during the baseline week as assessed by the daily diary;
  3. Use of an aid while walking, difficulty with standing upright or inability to walk 50 feet;
  4. Significant peripheral vascular disease (arterial or venous) causing pain on walking. History of intermittent claudication;
  5. Neurological disorders unrelated to diabetic neuropathy that may confound the assessment of distal neuropathic pain.
  6. Neurological or other disorders unrelated to diabetic neuropathy that might confound assessment of pain on walking (e.g plantar fasciitis) or other conditions (e.g, knee pain, arthritis) that could cause pain on walking;
  7. Pain due to other conditions, that in the opinion of the investigator, may confound assessment or self-evaluation of the pain due to diabetic neuropathy.
  8. Clinically significant unstable diabetes mellitus, or unstable hepatic, respiratory, or hematotlogic illnesses, unstable cardiovascular disease (including a myocardial infarction in the 3 months prior to visit 1/ Screening), or symptomatic peripheral vascular disease.
  9. Any amputation of lower extremities, foot ulcers involving the great toes, or presence of significant pedal edema;
  10. History or current evidence of any condition that could lead to impaired absorption of vitamin B12 ( Pernicious anemia, chronic gastritis of any cause, surgery such as gastrectomy or gastric bypass surgery, etc.).
  11. A history of untreated hypothyroidism in the past 12 months, or HIV infection;
  12. Have had a malignancy other than basal cell carcinoma or carcinoma in situ of the cervix within the past 5 years;
  13. Have creatinine clearance (CLcr) ≤ 60mL/min (estimated prior to Visit 2 from serum creatinine obtained at Visit 1, body weight, age, and gender using the Cockcroft and Gault equation;
  14. Abnormal (Clinically significant) electrocardiogram (ECG);
  15. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
  16. Currently receiving pregabalin or opioids for painful DPN. Subjects requiring opioid use are exluded. However, subjects may be eligible if opioids are washed out at least 4 weeks prior to V1 and following informed consent, if being discontinued as part of this study.
  17. Use of prohibited concomitant medications which cannot be safely washed out prior to study participation. Prohibited medications are : NSAIDs for DPN pain, opioids, benzodiazepines. NSAIDs used currently ( 2 times per week or less) to treat conditions other than DPN, are allowed.
  18. Participation in other studies within 30 days before the current study begins and/or during study participation.
  19. Any subject considered at risk of suicide or self-harm based on investigator judgment and/or the details of a risk assessment.
  20. Abuse of illicit drugs or alcohol within the last 2 years.
  21. Positive urine drug screen for drugs and alcohol.
  22. Unlikely to be able to comply with the protocol because of any reason.
  23. Pregnant females; breastfeeding females; males and females of childbearing potential not using highly effective contraception or not agreeing to continue highly effective contraception for at least 28 days after the last dose investigational product;
  24. Subjects who are investigational site staff members or relatives of those site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.
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