Diabetic Neuropathy, Painful; Diabetic Neuropathies Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled Crossover Study to Evaluate the Preliminary Efficacy of AZD5213 in Combination With Pregabalin in Subjects With Painful Diabetic Neuropathy and Good Pain Reporting Ability
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.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment