A Study Of Pregabalin in the Treatment Of Subjects with Painful Diabetic Peripheral Neuropathy with Background Treatment of Nsaid for other Pain Conditions. Print E-mail

Protocol# A0081268

Title: A Study Of Pregabalin in the Treatment Of Subjects with Painful Diabetic Peripheral Neuropathy with Background Treatment of Nsaid for other Pain Conditions.

INCLUSION CRITERIA:

  1. Diagnosis of type 1 or 2 diabetes mellitus with current hemoglobin A1C levels of ≤11%. Subject is to be on an antidiabetic treatment regimen and it must be stable for the 30 days prior to Visit 2.
  2. Diagnosis of painful, diabetic distal symmetrical sensorimotor polyneuropathy for at least 3 months.
  3. Currently treated with one NSAID (including COX-2 inhibitors) for a co-morbid pain condition with a regular dose (≥4 days/week) for at least 4 weeks prior to screening, and the ability to maintain the same treatment regimen during the study. The NSAID use must not be primarily for treating the subject's DPN pain.
  4. Meet the following 2 criteria demonstrating inadequate pain control: A score of ≥4 on the one-week recall, 11-point numerical rating scale for pain (Weekly-NRS Pain) at screening, Visit 1.AND at Visit 2, subjects must have completed at least 4 daily pain diaries over the past 7 days (baseline) and have an average daily pain score of  ≥4 on the 11-point numeric rating scale for pain (Pain Diary).
  5. Men or women who are at least 18 years of age.
  6. 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.
  7. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
  8. 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 IVRS.

EXCLUSION CRITERIA:

  1. Pain fluctuation ≥ 4 points determined by the difference between the highest and lowest pain score by Pain Diary during baseline period (the last 7 days prior to V2).
  2. Have failed pregabalin treatment due to lack of efficacy at therapeutic dose(s), have intolerance to pregabalin or any pregabalin ingredient, have used pregabalin within the last 30 days (prior to V1).
    Note: If the subject has taken pregabalin and discontinued for reasons other than lack of efficacy or intolerance (eg, economic burden), then they will be eligible.
  3. Participated in a previous or ongoing pregabalin clinical trial.
  4. Neurologic disorders unrelated to diabetic neuropathy that may confound the assessment of distal neuropathic pain.
  5. Skin conditions in the area affected by the neuropathy that could alter sensation.
  6. Other pain conditions (such as low back pain, osteoarthritis pain) that may confound the assessment or self-evaluation of the pain due to DPN.
  7. Clinically significant unstable diabetes mellitus, or unstable hepatic, respiratory, or hematologic illnesses, unstable cardiovascular disease (including a myocardial infarction in the 3 months prior to V1), or symptomatic (painful) peripheral vascular disease.
  8. Amputations due to diabetic complications of body parts other than toes.
  9. 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.)
  10. Untreated hypothyroidism, chronic hepatitis B, hepatitis B within the past 3 months, or known HIV infection.
  11. Have had a malignancy other than basal cell carcinoma or carcinoma in situ of the cervix within the
  12. Have creatinine clearance (CLcr) < 60 mL/min (estimated prior to Visit 2 from serum creatinine obtained at Visit 1, body weight, age, and gender using the Cockcroft and Gault equation). Subjects who have an estimated CLcr <60 mL/min by this screening method may have their CLcr measured, at the investigator’s discretion, with a 24-hour urine collection performed at the central laboratory. If this 24-hour urine CLcr is ≥ 60 mL/min, the subject is not excluded on the basis of this criterion.
  13. Clinically significant abnormal electrocardiogram (ECG) by the Investigators' discretion.
  14. 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.
  15. Use of prohibited concomitant meds which cannot be safely washed out prior to study participation. These medications include but are not limit to: those used to relieve neuropathic pain (other than underlying NSAIDs); antiepileptics (including gabapentin); antidepressants.
    Note
    : SSRIs for managing depression and/or anxiety are allowed if stable >30 days and can be maintained without change during the study.
  16. Currently receiving pregabalin or opioids (other than tramadol) for painful DPN.
  17. Participation in other studies in the 30 days before the current study begins and/or during study participation.
  18. Any subject considered at risk of suicide or self harm based on investigator judgment and/or the details of a risk assessment.
  19. Abuse of illicit drugs or alcohol within the last 2 years.
  20. Unlikely to be able to comply with the protocol because of social or other reasons.
  21. Subjects who are investigational staff members or relatives of those site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.

Have creatinine clearance (CLcr) < 60 mL/min (estimated prior to Visit 2 from serum creatinine obtained at Visit 1, body weight, age, and gender using the Cockcroft and Gault equation). Subjects who have an estimated CLcr <60 mL/min by this screening method may have their CLcr measured, at the investigator’s discretion, with a 24-hour urine collection performed at the central laboratory. If this 24-hour urine CLcr is ≥ 60 mL/min, the subject is not excluded on the basis of this criterion.

Clinically significant abnormal electrocardiogram (ECG) by the Investigators' discretion.

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.

Use of prohibited concomitant meds which cannot be safely washed out prior to study participation. These medications include but are not limit to: those used to relieve neuropathic pain (other than underlying NSAIDs); antiepileptics (including gabapentin); antidepressants.
Note: SSRIs for managing depression and/or anxiety are allowed if stable >30 days and can be maintained without change during the study.

Currently receiving pregabalin or opioids (other than tramadol) for painful DPN.

Participation in other studies in the 30 days before the current study begins and/or during study participation.

Any subject considered at risk of suicide or self harm based on investigator judgment and/or the details of a risk assessment.

Abuse of illicit drugs or alcohol within the last 2 years.

Unlikely to be able to comply with the protocol because of social or other reasons.

Subjects who are investigational 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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