Study of APD421 as PONV Treatment (no Prior Prophylaxis)
- Registration Number
- NCT02449291
- Lead Sponsor
- Acacia Pharma Ltd
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 568
Not provided
- Patients scheduled to undergo transplant surgery or any surgery where post-operative emesis may pose a significant danger to the patient
- Patients planned to receive only a local anaesthetic and/or regional neuraxial (intrathecal or epidural) block
- Patients who have received APD421 active ingredient for any indication within the last 2 weeks
- Patients who are allergic to APD421 active ingredient or any of the excipients of APD421
- Patients with a significant, ongoing history of vestibular disease or dizziness
- Patients being treated with regular anti-emetic therapy (dosed at least three times per week), which is still ongoing within one week prior to surgery
- Patients with a known prolactin-dependent tumour (e.g. pituitary gland prolactinoma or breast cancer) or phaeochromocytoma
- Patients being treated with levodopa
- Patients who are pregnant or breast feeding
- Patients with documented or suspected alcohol or substance abuse within the past 6 months
- Patients with a documented, clinically significant cardiac arrhythmia
- Patients diagnosed with Parkinson's disease
- Patients who have received emetogenic anti-cancer chemotherapy in the previous 4 weeks
- Patients with a history of epilepsy
- Any other concurrent disease or illness that, in the opinion of the investigator makes the patient unsuitable for the study
- Patients who have previously participated in this study or who have participated in another interventional clinical study involving pharmacological therapy within the previous 28 days (or longer exclusion period, if required by national or local regulations)
- Where local laws/regulations require: patients under legal protection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description APD421 standard APD421 Single (standard) dose IV APD421 APD421 high APD421 Single (high) dose IV APD421 Placebo Placebo Single IV placebo
- Primary Outcome Measures
Name Time Method Complete Response (Success of Initial PONV Treatment) 0-24 hours after 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.
- Secondary Outcome Measures
Name Time Method Number of Participants With Complete Response 0-2 Hrs 0-2 hours after administration of study medication 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.
Number of Participants With Complete Response 2-24 Hrs 2-24 hours after administration of study medication 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.
Number of Participants Using Rescue Medication 0-24 hours after study drug administration Proportion of patients receiving pre-specified anti-emetic rescue medication at any time in the 24 hours post-treatment period
Time to Treatment Failure 0-24 hours after study drug administration Time to first violation of the criteria for complete response
Incidence of Significant Nausea 30 mins to 24 hours after study drug administration 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.
Incidence of Nausea 30 mins to 24 hours after study drug administration 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.
Maximum Severity of Nausea 30 mins to 24 hours after study drug administration 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.
Number of Patients Experiencing Incidence of Emesis 30 mins to 24 hours after study drug administration Number of patients experiencing vomiting or retching during the time period from 30 minutes to 24 hours after administration of study medication
Evolution Score of Nausea (0-30 Mins) 0-30 minutes after study drug administration 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.
Trial Locations
- Locations (4)
Ohio State University
🇺🇸Columbus, Ohio, United States
Jackson Memorial Hospital
🇺🇸Miami, Florida, United States
CHU de Hautepierre
🇫🇷Strasbourg, France
Universität Heidelberg
🇩🇪Heidelberg, Germany