The Phase 3 double-blind, randomized, placebo-controlled study was designed to evaluate the safety and efficacy of pregabalin CR vs. placebo in the durability of effect for the treatment of pain associated with postherpetic neuralgia among patients who initially respond to single-blind pregabalin.
The study was composed of four phases: baseline (one week), single-blind treatment (six weeks), double-blind treatment (13 weeks), and a one-week double-blind taper. During the single-blind phase, participants received one out of two different doses of pregabalin. Patients with normal renal function received a dose between 165–660mg/day while patients with low renal function received between 82.5–330mg/day of pregabalin. In the double-blind phase, patients were randomized to continued pregabalin CR treatment at the optimized dose or to matching placebo.
The primary endpoint, defined as the time to loss of therapeutic response (LTR) during the double-blind phase (LTR; <30% pain response relative to the baseline mean pain or withdrawal due to lack of efficacy or adverse events), occurred in 29 of 208 (13.9%) patients in the pregabalin group as compared with 63 of 205 (30.7%) subjects in the placebo group. The difference between the treatments was statistically significant.
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