Study To Evaluate Efficacy, Safety And Tolerability Of Lyrica In Patients With Painful Diabetic Peripheral Neuropathy
Condition: Diabetic Neuropathy, Painful
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies; Pain
Intervention: Pregabalin; Placebo matched with pregabalin
Intervention description: Subjects in the pregabalin group will start treatment with pregabalin capsule 150 mg/day for 1 week, then their dose will be increased to 300mg/day. After 1-week titration period, dose must be stable during study, no dose adjustment is permitted, and subject who cannot tolerate 300 mg/day pregabalin will be withdrawn.
At the completion of the dose maintenance phase subjects will taper off study medication over a 1-week period. 300 mg/ day subjects will taper to 150 mg/ day.; Subject will take placebo matched with pregabalin twice a day.
Intervention MeSH terms: Pregabalin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 626.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetic Neuropathies; Pain; Efficacy of pregabalin; Placebo controlled

Summary:

      Pregabalin has proven effective in previous clinical trails in other countries in relieving
      neuropathic pain associated with postherpetic neuralgia and painful diabetic neuropathy.

      This study is being conducted according to China registration requirement to submit a
      reapplication with new local diabetic peripheral neuropathy study as a commitment plus the
      existing data to apply for Lyrica "pain associated with postherpetic neuralgia" indication
      after Lyrica "pain associated with postherpetic neuralgia" is approved.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects aged 18 years or older

          -  Diagnosis of painful, distal, symmetrical, sensorimotor polyneuropathy which is due to
             diabetes mellitus (Type 1 or 2), and symptoms of painful diabetic neuropathy for 6
             months to 5 years (inclusive).

          -  At the baseline and randomization visits, a score of ≥50 mm on the Visual Analogue
             Scale, at randomization, subjects must have completed at least 5 daily pain
             interference diaries, and have an average daily pain score of ≥5 over the past 7 days.

          -  Patient who are willing and capable to comply with scheduled visits, treatment plan,
             laboratory tests, and other study procedures.

          -  Women of childbearing potential are willing to use contraception during study.

        Exclusion Criteria:

          -  Subjects with more than 30% decrease on the Pain Visual Analog Scale at randomization
             as compared to screening; and during the 1 week screening period, with more than one
             pain score <3 in pain scores.

          -  Subject has other kinds of neurological disorder, pain of other reason, or skin
             condition that could confuse the assessment.

          -  Subject with any other serious or unstable condition which in the opinion of the
             investigator might compromise participation in the study.