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Antihistamine
Evaluation of Loratadine for Prevention of Pegfilgrastim-Induced Pain
Phase 2
Waitlist Available
Research Sponsored by University of Vermont
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one week after pegfilgrastim
Awards & highlights
All Individual Drugs Already Approved
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one week after pegfilgrastim
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one week after pegfilgrastim
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Prevention of pegfilgrastim-induced back and leg pain by administration of the antihistamine loratadine
Secondary study objectives
Identification of adverse events when loratadine is given to prevent pegfilgrastim-induced back and leg pain
Incidence of pegfilgrastim-induced back and leg pain
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: LoratadineActive Control1 Intervention
Loratadine 10 mg once a day for 7 days beginning the day of pegfilgrastim treatment in patients with pegfilgrastim-induced back and leg pain during the previous treatment cycle
Group II: PlaceboPlacebo Group1 Intervention
Placebo once a day for 7 days beginning the day of pegfilgrastim treatment in patients with pegfilgrastim-induced back and leg pain during the previous treatment cycle
Find a Location
Who is running the clinical trial?
University of VermontLead Sponsor
278 Previous Clinical Trials
3,744,089 Total Patients Enrolled
Cancer and Leukemia Group BNETWORK
80 Previous Clinical Trials
117,933 Total Patients Enrolled
Steven M Grunberg, MDStudy ChairUniversity of Vermont
1 Previous Clinical Trials
37 Total Patients Enrolled