Safety, Tolerability and Preliminary Efficacy of AZD5213 in Combination With Pregabalin in Subjects With PDN and Good Pain Reporting Ability
Condition: Diabetic Neuropathy, Painful; Diabetic Neuropathies
MeSH terms: Diabetic Neuropathies; Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a 2-part study. In Part 1 of the study, subjects will undergo a pain reporting
      training program in which a painful stimulus will be applied to the subject's hand, and the
      subjects will be asked to report how painful the stimulus is. Over the course of the pain
      training sessions, feedback will be provided to the subject about how accurately they are
      reporting their degree of pain, relative to the amount of pressure stimulus applied to evoke
      pain. Those subjects who have adequate pain reporting ability will be asked to continue into
      Part 2 of the study in which 3 different blinded study drugs will be administered to each
      subject, in a crossover design to compare whether or not the study drugs improve pain
      associated with diabetic neuropathy.
    

Detailed description: 
      This is a multi-center, randomized, two-part study in adults (ages 18-75 years) with Painful
      Diabetic Neuropathy (PDN).

      In Part 1 of the study, eligible subjects will enter a 4-week Pain Training Period. During
      the Pain Training Period, subjects will receive three weekly in-clinic training sessions
      using repeated rating of experimental pressure pain stimuli. Subjects will receive feedback
      during this training and will be evaluated on their pain-reporting ability during each
      in-clinic session. Subjects with acceptable pain-reporting ability at the conclusion of the
      Pain Training Period will be eligible to enter Part 2 of the study. Subjects with
      unacceptable pain-reporting ability at the conclusion of the Pain Training Period will be
      discontinued from the study.

      Part 2 of the study will consist of three consecutive double-blind crossover periods. Each
      crossover period will include 31 days of double-blind treatment. A follow-up visit will occur
      14 ± 7 days after the last dose of study medication.

      One of three treatments (placebo, pregabalin, or pregabalin + AZD5213) will be administered
      during each crossover treatment period, as determined by a randomly assigned treatment
      sequence.

      Approximately 65 subjects will be screened in Part 1 of the study, in order to randomize up
      to approximately 32 subjects in Part 2 of the study.
    

Intervention name(s): AZD5213 + pregabalin; Placebo; pregabalin capsules
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Double blind Investigational drug AZD5213 (capsules) given in combination with pregabalin (capsules); Double blind placebo capsules to match AZD5213 and pregabalin; Double blind pregabalin capsules to match AZD5213 and placebo
Other intervention name(s): pregabalin (LYRICA); LYRICA (pregabalin)
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment