Evaluation of the safety and efficacy of an intravenous nanocrystal formulation of meloxicam in the management of moderate-to-severe pain after bunionectomy

Journal of Pain Research
Ira J GottliebWei Du

Abstract

This randomized, double-blind, placebo-controlled study evaluated the safety and efficacy of an intravenous (IV) nanocrystal formulation of meloxicam in subjects with moderate-to-severe pain following a standardized unilateral bunionectomy. Fifty-nine subjects aged 18-72 years were randomized to receive doses of either 30 mg (n=20) or 60 mg (n=20) meloxicam IV or placebo (n=19), administered once daily as bolus IV injections over 15-30 seconds (two or three doses). Safety, the primary objective, was assessed by physical examination, clinical laboratory tests, and the incidence of adverse events (AEs). Efficacy was evaluated by examining summed pain intensity differences over the first 48 hours (SPID48) using analysis of covariance models. Use of opioid rescue analgesic agents was evaluated. Generally, AEs were mild-to-moderate in intensity, and their incidence was similar across the three treatment groups. No serious AEs were reported; there were no withdrawals due to AEs, including injection-related AEs. The estimated effect size for SPID48versus placebo was 1.15 and 1.01 for meloxicam IV doses 30 mg and 60 mg, respectively (P≤0.01). Both doses produced significantly greater pain reductions versus placebo (P≤0.05) at all evalu...Continue Reading

Citations

Feb 21, 2019·Clinical Pharmacology in Drug Development·Sergio D BergeseJorge E Marcet
Jan 22, 2020·Clinical Pharmacology in Drug Development·Jonathan S JahrSue Hobson
Oct 3, 2018·Plastic and Reconstructive Surgery. Global Open·Neil SinglaWei Du
Feb 1, 2020·Current Pain and Headache Reports·Alan David KayeElyse M Cornett
Jul 1, 2020·Regional Anesthesia and Pain Medicine·Katarzyna Korwin-KochanowskaUNKNOWN PROSPECT/ESRA Working Group Collaboration
Oct 29, 2020·BMC Anesthesiology·John A CarterJonathan S Jahr
Jan 28, 2021·Pain Medicine : the Official Journal of the American Academy of Pain Medicine·Richard D BerkowitzErin Coyle

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NCT02675907

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