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Evaluation of Loratadine for Prevention of Pegfilgrastim-Induced Pain

NCT01311336 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2013-01-24

No results posted yet for this study

Summary

The purpose of this study is to determine the incidence of pegfilgrastim-induced back and leg pain and to determine whether the antihistamine loratadine can prevent pegfilgrastim-induced back and leg pain.

Conditions

  • Pegfilgrastim-induced Back and Leg Pain

Interventions

DRUG

Loratadine

loratadine 10 mg capsule orally once daily for 7 days beginning the day of administration of pegfilgrastim

DRUG

placebo

placebo capsule orally once daily for 7 days beginning the day of administration of pegfilgrastim

Sponsors & Collaborators

  • Cancer and Leukemia Group B

    collaborator NETWORK

  • University of Vermont

    lead OTHER

Principal Investigators

  • Steven M Grunberg, MD · University of Vermont

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01311336 on ClinicalTrials.gov