NCT01311336

Evaluation of Loratadine for Prevention of Pegfilgrastim-Induced Pain

Randomized Phase II Pilot Study of Loratadine for the Prevention of Pain Caused by the Granulocyte Colony Stimulating Factor Pegfilgrastim

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: University of Vermont · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Pegfilgrastim is a myeloid growth factor that stimulates neutrophil precursors and can be used to decrease infection risk associated with neutropenia. However pegfilgrastim may induce back and leg pain in 20-50% of patients. No intervention has been consistently successful in treating or preventing this pain. The exact mechanism of pegfilgrastim-induced pain is unknown but may be related to histamine-mediated inflammation. Several case reports and anecdotal reports have suggested efficacy of antihistamines for this indication. This study will have two parts. In the first part (Observational Phase), patients receiving pegfilgrastim will be surveyed to document the incidence of significant pegfilgrastim-induced back and leg pain. In the second part (Treatment Phase), patients who previously experienced such pain will be randomized to receive a 7-day course of either the antihistamine loratadine or placebo to determine whether pegfilgrastim-induced back and leg pain can be prevented with this intervention.

Conditions

• Pegfilgrastim-induced Back and Leg Pain

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-05-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2011-03-09
• Last updated: 2013-01-24

Locations

7 sites across 1 country: United States