UC Irvine

This multicenter, double-blind, randomized, parallel study compared the efficacy and safety of two dosages of naproxen sodium (NS) in 100 patients with bone pain due to metastatic cancer. Patients were asked to rate their pain on a scale of 0-99; those patients with pain scores of 40 or more (indicating moderate to severe pain) were enrolled. Patients receiving the high-dosage regimen (HDR; n = 51) received NS 550 mg every 8 h for 3 days. Those receiving the low-dosage regimen (LDR; n = 49) received on day 1 an initial dose of NS 550 mg followed by NS 275 mg capsules every 8 h through day 3. Patients evaluated pain intensity 8 times/day. During use of NS, pain intensity scores decreased by approximately one-third in each treatment group. Among patients who responded to NS, pain relief with the HDR was significantly greater than with the LDR. Differences between regimens in adverse events during treatment were non-significant; complaints were mainly gastrointestinal and mild.