CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 600 enrolled
Drug / intervention
Naproxen +3 moredrug
Likely dose
Pegfilgrastim 6 mgfrom 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/NCT01712009
NCT01712009Phase 2Completed
CompareCT.gov

Randomized, Phase 2 Study to Estimate the Effect of Prophylactic Intervention With Naproxen or Loratadine on Bone Pain in Breast Cancer Subjects Receiving Chemotherapy and Pegfilgrastim

Amgen·interventional·Posted Oct 23, 2012·Updated Jan 30, 2018

In Brief

A Phase 2 clinical trial evaluating Naproxen, Loratadine, and 2 other interventions for Bone Pain in Stage I - III Breast Cancer. Completed, enrolled 600 participants across 83 sites.

Detailed Summary

The primary objective of the study is to estimate the difference in bone pain between breast cancer patients receiving chemotherapy and pegfilgrastim and either no prophylactic intervention, prophylactic naproxen, or prophylactic loratadine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBone Pain in Stage I - III Breast Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 23, 2012
Enrollment StartNov 1, 2012
Primary CompletionMar 18, 2015
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 13.7 years ago

Interventions

Naproxendrug

Loratadinedrug

Pegfilgrastimbiological

Commercially available pegfilgrastim (Neulasta®) will be used in the study, and is considered background therapy. Pegfilgrastim is administered as a single 6 mg subcutaneous injection 24 hours to 72 hours after completion of chemotherapy.

Chemotherapydrug

The choice of chemotherapy regimen (agent, dose, and schedule) is at the discretion of the treating physician.