CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 510 enrolled
Drug / intervention
naproxen +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00602420
NCT00602420Phase 3Completed
CompareCT.gov

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

Gary Morrow·interventional·Posted Jan 28, 2008·Updated Nov 9, 2015

In Brief

A Phase 3 clinical trial evaluating naproxen and placebo for Musculoskeletal Complications and 2 related conditions. Completed, enrolled 510 participants across 16 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMusculoskeletal Complications, Pain, Unspecified Adult Solid Tumor, Protocol Specific
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 28, 2008
Enrollment StartJun 1, 2008
Primary CompletionJan 1, 2012
Study CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 18.4 years ago

Interventions

naproxendrug

Oral naproxen twice daily for 5-8 days.

placeboother

Oral placebo twice daily for 5-8 days.