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 not had prior PONV prophylaxis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
568
Jackson Memorial Hospital
Miami, Florida, United States
Ohio State University
Columbus, Ohio, United States
CHU de Hautepierre
Strasbourg, France
Universität Heidelberg
Heidelberg, Germany
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 treatment
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 2-24 Hrs
Success of initial PONV treatment, where success is defined as no emetic episodes (vomiting or retching) and no administration of anti-emetic rescue medication from 2 to 24 hours after administration of study medication.
Time frame: 2-24 hours after administration of study medication
Time to Treatment Failure
Time to first violation of the criteria for complete response
Time frame: 0-24 hours after study drug administration
Number of Patients Experiencing 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
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Number of Participants Using Rescue Medication
Proportion 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
Incidence of Significant Nausea
Proportion 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
Incidence of Nausea
Proportion 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 study 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 (0-30 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 four pre-planned time points: pre-dose (0-min), and 5, 15 and 30 minutes 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: 0-30 minutes after study drug administration