Phase IIIb Study of APD421 in Combination as PONV Prophylaxis

Acacia Pharma Ltd1,147 enrolled

Overview

A comparison of the efficacy of APD421 and placebo when combined with a standard anti-emetic in the prevention of PONV in patients at high risk of Post-operative Nausea and Vomiting (PONV).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

1,147

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 * Patients with at least 3 "Apfel" risk factors for PONV Exclusion Criteria: * Patients scheduled to undergo transplant 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 (25)

Helen Keller Hospital

Sheffield, Alabama, United States

Outcomes

Primary Outcomes

Number of Participants With Complete Response

Complete response defined as no emesis and no use of rescue medication in the 24 hour period after end of surgery (defined as wound closure)

Time frame: 24 hours after the end of surgery

Secondary Outcomes

Number of Participants With Emesis

Emesis is defined as vomiting (production of even the smallest amount of stomach contents) or retching (muscular movements of vomiting but without expulsion of stomach contents, usually because of an empty stomach)

Time frame: 24 hours after the end of surgery

Number of Participants Receiving Rescue Medication

Rescue medication defined as an antiemetic (or other medication) given with the intention of relieving nausea and/or emesis, or any incidental use of a drug known to have antiemetic potential

Time frame: 24 hours after the end of surgery

Number of Participants With Any Nausea

Nausea (defined as the desire to vomit without the presence of expulsive muscular movements) measured on a 0-10 verbal response scale, where 0=no nausea at all and 10=the worst nausea imaginable. "Any nausea" means a score ≥ 1.

Time frame: 24 hours after the end of surgery

Number of Participants With Significant Nausea

Time frame: 24 hours after end of surgery

Time to First Violation of Criteria for PONV

Criteria for PONV are any episode of emesis or use of rescue medication in the 24 hours after the end of surgery

Data from ClinicalTrials.gov

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