A Study to Test the Effectiveness of Pregabalin in Relieving Symptoms of Patients with Diabetic Peripheral Neoropathy who also Uses an Anti-Inflammatory Drug for Another Condition.

• Conditions: painful diabetic peripheral neuropathy; MedDRA version: 14.1Level: LLTClassification code 10012683Term: Diabetic peripheral neuropathySystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2011-002743-10-IT
• Lead Sponsor: PFIZER INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-02
• Last Update Posted: 10 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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 (refer to Appendix 1 for diagnostic worksheet). 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. 090177e1822933c3\Approved\Approved On: 26-Jul-2011 16:54 Pregabalin A0081268 Final Protocol, 22 July 2011 PFIZER CONFIDENTIAL Page 15 of 79 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.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

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 past 5 years. 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; see Section 7). 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of pregabalin compared with placebo for the symptomatic relief of DPN pain in subjects with painful DPN who use one NSAID (including COX-2 inhibitors) primarily for the treatment of conditions other than DPN pain.;Secondary Objective: 1)To evaluate the efficacy of pregabalin compared with placebo treatment to improve subject global assessment, sleep, quality of life associated with DPN, and time to loss of pain response. 2)To evaluate the safety and tolerability of pregabalin.;Primary end point(s): Endpoint mean pain score, based on the mean of the last 7 daily pain numeric rating scale (NRS) scores from the daily pain diaries while receiving study medication in each treatment period (eg, daily pain diary (0-10 numeric rating scale)).;Timepoint(s) of evaluation of this end point: Reduction in DPN pain, as from the daily pain diaries while receiving study medication in each treatment period (V2-V6 & V7-V11)