Broadening Antiemetics Research by Comparing the Effectiveness of Fosaprepitant and Metoclopramide
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMontefiore Medical Center
About this trial
The study team proposes a double-blind, comparative effectiveness, randomized controlled trial (RCT) to address the following goal: to determine the relative efficacy and adverse event profile of fosaprepitant compared to the standard of care antiemetic metoclopramide. Fosaprepitant and its active metabolite aprepitant are a relatively new class of antiemetic that exclusively acts in the central nervous system by blocking neurokinin (NK-1) which is a key signaling molecule in the centrally mediated aspects of the vomiting reflex. Currently, fosaprepitant and aprepitant both have only two United Stated Food and Drug Administration (USFDA) approved indications for nausea and vomiting: chemotherapy-induced and postoperative. Neurokinin inhibitors are highly effective and generally well-tolerated. Therefore, this class of medication may be a more appropriate medication for the millions of patients with nausea and vomiting that seek care in emergency departments (EDs). Intravenous fosaprepitant is converted to the active metabolite aprepitant on the order of minutes and is significantly cheaper to procure at this time.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults at least 18 years old
Present to ED for treatment of Nausea and/or vomiting as defined by the International Classification of Diseases (ICD-10) or identified by treating clinician
Disqualifiers
Pregnancy, desiring pregnancy, or lactating
Antiemetic use or intravenous fluids prior to presenting to ED for evaluation and management
Bradycardia (< 60 bpm heart rate)
Prolonged QTc (greater than 490ms)
Trial design
Design model
Parallel
Treatments tested in this trial
Fosaprepitant for Injection
DrugFosaprepitant 150mg IV administered over 15 minutes
Metoclopramide Injection
DrugMetoclopramide 10mg IV administered over 15 minutes
Treatment groups
212 Participants
are divided into 2 treatment groupsGroup A: Investigational InterventionExperimental treatment 1 intervention
Group B: Standard-of-Care InterventionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Sustained Nausea and Vomiting (NV) Relief
The primary efficacy outcome for this study will be sustained relief from NV at 2 hours following medication administration. Sustained relief from NV will be determined by the intensity of nausea reported by patients following administration of antiemetic. Intensity of nausea will be reported as either "None", "Mild", "Moderate" or "Severe." The number/percentage of patients reporting each degree of nausea intensity at 2 hours will be summarized by study arm. Sustained relief of NV requires a patient to present with a nausea intensity of either "Severe" or "Moderate," which is then reduced by treatment to at least "Mild" or None," within 2 hours of medication administration without the use of any rescue medication. Patients who do not report an initial nausea intensity of either "Severe" or "Moderate" will not be assessed as they are not eligible for the study.
Time frame
2 hours (assessed at the 2-hour mark after administration of the intervention)2
Development of New Symptom
The primary tolerability outcome for this study will be the onset of any new symptoms within 2 hours after medication administration. Onset of symptoms will be assessed by asking patients if they developed any new symptoms after administration of the investigational medication. Symptoms will be elicited using an open-ended format. Patients who confirmed that they had experienced new symptoms will be asked to grade the severity of the new symptom(s) using the descriptors "Mild", "Moderate", or "Severe". The frequency and intensity of new symptoms will be summarized by study arm using basic descriptive statistics.
Time frame
2 hours (assessed at the 2-hour mark after administration of the intervention)Secondary outcomes
1
Sustained NV Relief
Sustained relief from NV will be determined by the intensity of nausea reported by patients following administration of antiemetic. Intensity of nausea will be reported as either "None", "Mild", "Moderate" or "Severe." The number/percentage of patients reporting each degree of nausea intensity at 24 hours will be summarized by study arm. Sustained relief of NV requires a patient to present with a nausea intensity of either "Severe" or "Moderate," which is then reduced by treatment to at least "Mild" or "None," within 2 hours of medication administration AND maintained at "Mild" or "None" level for the entire 24-hour period following medication administration, without the use of rescue medication.
Time frame
24 hours following medication administration2
NV Relief
Relief of NV over time will be determined by the intensity of nausea reported by patients following administration of antiemetic. Intensity of nausea will be reported as either "None", "Mild", "Moderate" or "Severe" and assessed every 15 minutes during the first 2 hours, then every hour after that up to 24 hours. The number/percentage of patients reporting each degree of nausea intensity at each timepoint will be summarized by study arm using basic descriptive statistics. Sustained relief of NV requires a patient to present with an initial nausea intensity of either "Severe" or "Moderate" and assessments will only be made in patients who did not need rescue medication.
Time frame
24 hours (measured every 15 minutes for the first 2 hours, then hourly after that until final disposition; reassessed at 24 hours)3
NV Freedom
Freedom from NV over time will be determined by the intensity of nausea reported by patients following administration of antiemetic. Intensity of nausea will initially be reported as either "None", "Mild", "Moderate" or "Severe" and assessed every 15 minutes during the first 2 hours, then every hour after that up to 24 hours. The number/percentage of patients reporting a nausea intensity of "None" will be summarized by study arm using basic descriptive statistics. Sustained freedom from NV requires a patient to present with an initial nausea intensity of either "Severe" or "Moderate" and assessments will only be made in patients who did not receive rescue medication.
Time frame
24 hours (measured every 15 minutes for the first 2 hours, then hourly after that until final disposition; reassessed at 24 hours)4
Sustained NV Freedom
Sustained NV Freedom will be determined by the intensity of nausea reported by patients following administration of antiemetic. Intensity of nausea will initially be reported as either "None", "Mild", "Moderate" or "Severe." The number/percentage of patients reporting a nausea intensity of "None" will be summarized by study arm using basic descriptive statistics. Sustained NV Freedom requires a patient to present with a nausea intensity of either "Severe" or "Moderate," which is then reduced by treatment to "None" within 2 hours of medication administration AND maintained at the same ("None") level for the entire 24-hour period following medication administration, without the use of rescue medication.
Time frame
24 hours following medication administrationOther outcomes
1
Severity of Nausea
Severity of nausea will be evaluated based on responses to a visual analogue scale ranging from 0 to 100 (0 = no nausea, 100 = worst nausea possible). Mean scores will be summarized and reported by study arm. Higher scores are associated with increased severity of nausea.
Time frame
24 hours (measured every 15 minutes for the first 2 hours, then hourly after that until disposition; reassessed at 24 hours)2
QTc Interval (QT interval corrected for heart rate)
Mean QTc durations, as calculated from electrocardiogram (ECG) readings administered prior to receiving intervention, and at disposition, will be determined. Mean QTc durations will be summarized by study arm. Prolonged QT interval is commonly associated with antiemetics and can often be a prelude to cardiac dysrhythmias associated with mortality.
Time frame
Prior to Intervention and at disposition, approximately 2 hours3
Need for rescue antiemetic medication
The need for rescue antiemetic medication during the study will be assessed using a binary outcome (i.e., "Yes: or "No") to summarize whether additional dosing of antiemetic medication to treat nausea was needed. Results will be summarized by study arm using basic descriptive statistics.
Time frame
2 hours (assessed at the 2-hour mark after administration of the intervention)4
Vomiting Episodes
The mean number of vomiting episodes per patient over the past 24 hours will be assessed and summarized by study arm.
Time frame
Up to 24 hoursSponsors and contacts
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Source ClinicalTrials.gov
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