Double-blind, randomised, parallel-group, placebo-controlled, adaptive, seamless, dose-selecting study to compare the efficacy of APD421 to placebo as treatment of established PONV, in patients who have had prior PONV prophylaxis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
705
Jackson Memorial Hospital
Miami, Florida, United States
Duke University Medical Center
Durham, North Carolina, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States
Ohio State University
Columbus, Ohio, United States
Number of Participants With Complete Response (Success of Initial PONV Treatment)
The primary efficacy variable was the dichotomous variable: success or failure of initial PONV treatment, where success is defined as no emetic episodes (vomiting or retching) from 30 minutes\* to 24 hours after administration of study medication and no administration of anti-emetic rescue medication at any time in the 24-hour period after administration of study medication.
Time frame: 0-24 hours after administration of study medication
Number of Participants With Complete Response 0-2 Hrs
Success of initial PONV treatment, where success is defined as no emetic episodes (vomiting or retching) from 30 minutes\* to 2 hours after administration of study medication and no administration of anti-emetic rescue medication at any time in the 2-hour period after administration of study medication.
Time frame: 0-2 hours after administration of study medication
Number of Participants With Complete Response 0-4 Hrs
Success of initial PONV treatment, where success is defined as no emetic episodes (vomiting or retching) from 30 minutes\* to 4 hours after administration of study medication and no administration of anti-emetic rescue medication at any time in the 4-hour period after administration of study medication.
Time frame: 0-4 hours after administration of study medication
Number of Participants With Complete Response 0-6 Hrs
Success of initial PONV treatment, where success is defined as no emetic episodes (vomiting or retching) from 30 minutes to 6 hours after administration of study medication and no administration of anti-emetic rescue medication at any time in the 6-hour period after administration of study medication.
Time frame: 0-6 hours after administration of study medication
Time to Treatment Failure
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CHU de Hautepierre
Strasbourg, France
HELIOS Klinikum Aue
Aue, Germany
Universität Heidelberg
Heidelberg, Germany
Philipps University
Marburg, Germany
Time to first violation of the criteria for complete response
Time frame: 0-24 hours after study drug administration
Number of Patients With Incidence of Emesis
Number of patients experiencing vomiting or retching during the time period from 30 minutes to 24 hours after administration of study medication
Time frame: 30 mins to 24 hours after study drug administration
Number of Patients Receiving Rescue Medication
Number of patients receiving pre-specified anti-emetic rescue medication at any time in the 24 hours post-treatment period
Time frame: 0-24 hours after study drug administration
Number of Patients With an Incidence of Significant Nausea
Number of patients with nausea score ≥4 on an 11-point verbal rating scale (0=no nausea, 10=worst possible nausea, therefore higher value is worse outcome) during the time period from 30 minutes to 24 hours after administration of study medication.
Time frame: 30 mins to 24 hours after study drug administration
Number of Patients With an Incidence of Nausea
Number of patients with nausea score ≥1 on an 11-point verbal rating scale (0=no nausea, 10=worst possible nausea, therefore higher value is worse outcome) during the time period from 30 minutes to 24 hours after administration of study medication.
Time frame: 30 mins to 24 hours after drug administration
Maximum Severity of Nausea
Highest recorded nausea score on an 11-point verbal rating scale (0=no nausea, 10=worst possible nausea, therefore higher value is worse outcome) during the time period from 30 minutes to 24 hours after administration of study medication.
Time frame: 30 mins to 24 hours after study drug administration
Evolution Score of Nausea (0-180 Mins)
The evolution score of nausea was calculated as the area under the curve (AUC) of the nausea scores on a scale 0-10 (where 0 is no nausea and 10 is the worst nausea imaginable) obtained at five pre-planned time points: pre-dose (0-min), and 5, 15 and 30 minutes and 2 hours after administration of study medication, as well as any spontaneously reported episodes of nausea during the time period, plotted against time. A higher score represents a worse outcome.
Time frame: 0-180 minutes after study drug administration