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Prevention of Pegfilgrastim-Induced Bone Pain (PIBP)

NCT00602420 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 510

Last updated 2015-11-09

Study results available
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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.

Conditions

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

Interventions

DRUG

naproxen

Oral naproxen twice daily for 5-8 days.

OTHER

placebo

Oral placebo twice daily for 5-8 days.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Gary Morrow

    lead OTHER

Principal Investigators

  • Jeffrey J. Kirshner, MD · CCOP - Hematology-Oncology Associates of Central New York

  • Gary R. Morrow, PhD, MS · University of Rochester

  • Jeffrey K. Giguere, MD, FACP · CCOP - Greenville

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2012-01-31
Completion
2012-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00602420 on ClinicalTrials.gov