European Phase III Study of APD421 in PONV

Phase 3CompletedNCT01991821

Acacia Pharma Ltd368 enrolled

Overview

A comparison of the efficacy of APD421 and placebo in the prevention of PONV in patients at moderate-to-high risk of PONV.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

368

Conditions

PONV

Interventions

APD421DRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female patients ≥ 18 years of age * Patients undergoing elective surgery (open or laparoscopic technique) under general anaesthesia, expected to last at least one hour from induction of anaesthesia to wound closure and expected to require at least one overnight stay in hospital Exclusion Criteria: * Patients scheduled for outpatient/day case surgery * Patients scheduled to undergo intra-thoracic, transplant or central nervous system surgery * Patients scheduled to receive only a local anaesthetic/regional neuraxial (intrathecal or epidural) block * Patients who are expected to remain ventilated for a period after surgery * Patients who are expected to need a naso- or orogastric tube in situ after surgery is completed

Locations (2)

CHU de Hautepierre

Strasbourg, France

University Hospitals of Würzburg

Würzburg, Germany

Outcomes

Primary Outcomes

Complete Response (no Emesis, Significant Nausea or Rescue Medication)

The primary efficacy analysis was a comparison of the incidence of Complete Response (absence of PONV1) in the 0-24-hour period after surgery, between the active treatment group and the placebo group using Pearson square test with Yates's continuity correction at a two-sided significance level of 5%.

Time frame: 24 hours after end of surgery

Secondary Outcomes

Complete Response (no Emesis or Rescue Medication)

Time frame: 24 hrs after end of surgery

Total Response (no Emesis, Nausea or Rescue Medication)

Time frame: 24 hrs after end of surgery

Incidence of Emesis (Vomiting/Retching)

An assessment of a participant experiencing an episode of emesis (vomiting/ retching) or received anti-emetic rescue medication during the 24hours after the completion of the surgery

Time frame: 24 hours after end of surgeryry

Incidence of Nausea

Count of patients experiencing an episode of nausea scored ≥ 1 of 0-10 verbal response scale during the 24 hours period after the completion of surgery

Time frame: 24 hours after end of surgery

Incidence of Significant Nausea

Count of participants with nausea score ≥ 4 on 0-10 verbal response scale

Time frame: 24 hours after end of surgery

Use of Rescue Medication

Time frame: 24 hours after end of surgery

Data from ClinicalTrials.gov

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