Prevention of Pegfilgrastim-Induced Bone Pain (PIBP)

Summary

RATIONALE: Naproxen may help prevent or lessen bone pain caused by pegfilgrastim. It is not yet known whether naproxen is more effective than a placebo in preventing bone pain caused by pegfilgrastim in patients with non-hematologic cancer undergoing chemotherapy. PURPOSE: This randomized phase III trial is studying naproxen to see how well it works compared with a placebo in preventing bone pain caused by pegfilgrastim in patients with non-hematologic cancer undergoing chemotherapy.

Timeline

Start

2008-06

Primary completion

2012-01

Completion

2012-03

Outcome

Met primary endpoint

registry analysis (superiority or other test); Naproxen vs Placebo; p = 0.037; Mean Difference (Final Values) 1.67 (95% CI 0.10 to 3.24); t-test, 2 sided NCT00602420 ↗

Drugs

Indications