A total of 441 subjects were enrolled into the SB phase from 49 sites in 4 countries (U.S., Canada, India, and Taiwan). Of the 441 subjects, 122 (28%) completed SB, had ≥50% pain response (i.e., ≥50% reduction in pain compared to baseline) and were randomized into DB. 122 subjects completed the single-blind phase and were randomized to the double-blind phase. One subject discontinued following randomization without receiving double-blind study medication, so 121 subjects received double-blind study medication and are included in the full analysis set.The primary endpoint, defined as the time to loss of therapeutic pain response during DB (LTR; <30% pain response relative to the SB baseline mean pain or withdrawal due to lack of efficacy or adverse events), occurred in 34 of 63 (54.0%) patients in the pregabalin group as compared with 41 of 58 (70.7%) subjects in the placebo group. The median time from randomization to LTR was 58 days in the pregabalin group and 22 days in the placebo group. The difference between the treatments was statistically significant (log-rank p-value=0.021).
Pfizer Reports Top-Line Results Of A Phase 3 Study Evaluating Pregabalin Controlled-Release As Treatment For Patients With Fibromyalgia
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