ARTICLE | Clinical News

Meloxicam: Ph III data

December 2, 2016 4:43 PM UTC

Top-line data from a double-blind, U.S. Phase III trial in 219 patients showed that 30 mg IV meloxicam every 24 hours for up to 3 doses following abdominoplasty met the primary endpoint of improving SPID24 vs. placebo (p=0.0145). Recro said meloxicam also met 10 secondary endpoints vs. placebo, including reducing the number of times patients required rescue during the hours 0-24 (p=0.0275) and hours 24-48 (p=0.0009), reducing time to perceptible pain relief (p=0.005), improving SPID12 (p=0.0434) and a greater proportion of patients with ≥30% improvement at 24 hours (p=0.0178). Meloxicam missed the secondary endpoints measuring time to meaningful pain relief, number of patients rescued in the first 24 and 48 hours, SPID6, time to first rescue, proportion of patients with ≥30% improvement at 6 hours and ≥50% improvement at 6 and 24 hours and PGA of pain control at 24 hours. ...

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