NCT00602420

Prevention of Pegfilgrastim-Induced Bone Pain (PIBP)

Prevention of Pegfilgrastim-Induced Bone Pain (PIBP): A Phase III Double-Blind Placebo-Controlled Clinical Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 510 (actual)
• Sponsor: Gary Morrow · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Detailed description

OBJECTIVES: Primary * To compare the efficacy of daily administration of naproxen vs placebo in preventing or reducing the severity and duration of pegfilgrastim-induced bone pain (PIBP) in patients with non-hematologic malignancies undergoing chemotherapy. Secondary * To identify potential risk factors for the development of PIBP. * To identify potential clinical predictors for the response or failure to respond to naproxen in preventing PIBP. * To assess the toxicity of naproxen when administered in the preventive setting. OUTLINE: This is a multicenter study. Patients are stratified by Clinical Community Oncology Program (CCOP) site. Patients are randomized to 1 treatment arm vs placebo. * Arm I: Patients receive oral naproxen twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days. * Arm II: Patients receive matching placebo twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.

Conditions

• Musculoskeletal Complications
• Pain
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	naproxen	Oral naproxen twice daily for 5-8 days.
OTHER	placebo	Oral placebo twice daily for 5-8 days.

Timeline

• Start date: 2008-06-01
• Primary completion: 2012-01-01
• Completion: 2012-03-01
• First posted: 2008-01-28
• Last updated: 2015-11-09
• Results posted: 2015-05-12

Locations

16 sites across 1 country: United States