The purpose of this study is to determine the best way to conduct clinical trials in patients with neuropathic pain (nerve pain). This study will see if generic pregabalin has any effect on neuropathic pain.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
104
pregabalin (up to 600 mg/day by mouth (po)). Duration of Treatment: 6 Weeks
pregabalin Pbo (up to 600 mg/day by mouth (po)). Duration of Treatment: 6 Weeks
Daily Evening Patient Reported Pain Intensity Scores
Change from mean of last 3 days of maintenance period to last 3 days of double-blind period; Pain Intensity was rated on a 0-10 numeric rating scale (NRS: 0=no pain, 10=worst pain you can imagine)
Time frame: Baseline and 6 Weeks
'Time to Efficacy Failure' During the Randomized Withdrawal Portion of the Study
Time to treatment failure (3 day mean of average 24 hour pain intensity ≥ 4 with at least a 30% increase relative to the last 3 days prior to randomization)
Time frame: 6 Weeks
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