US Phase III Study of APD421 in PONV

Phase 3CompletedNCT01991860

Acacia Pharma Ltd364 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

364

Conditions

PONV

Interventions

APD421- Amisulpride for IV injectionDRUG

APD421 ( Amisulpride) at 5mg given by single intravenous (IV) administration, by slow push over one minute, at induction of anaesthesia

PlaceboDRUG

Matching Placebo given by single intravenous (IV) administration, by slow push over one minute, at induction of anaesthesia

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 (1)

Duke

Durham, North Carolina, United States

Outcomes

Primary Outcomes

Number of Participants With Complete Response

The primary efficacy analysis was a comparison of the incidence of Complete Response, defined as no emesis (vomiting or retching) and no use of rescue medication in the 24 hours after the end of surgery, between the active group and the placebo group using Pearson χ2 test with Yates's continuity correction, and with a two-sided significance level of 5%.

Time frame: 24 hours after the end of surgery

Secondary Outcomes

Number of Participants With no 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. "No nausea" means no score ≥ 1.

Time frame: 24 hours after end of surgery

Number of Participants With no 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 end of surgery

Number of Participants With no Use of Rescue Medication

Any agent given in the post-operative period with the intention of providing anti-emetic rescue was counted as rescue anti-emetic medication for the purposes of efficacy determination, even if it did not achieve control of emesis or was given incorrectly (e.g., wrong dosage or route). Any agent given in the post-operative period which would be expected, by virtue of its pharmacology, dosage and route, to exert a clinically meaningful anti-emetic effect was considered as rescue anti-emetic medication, even if administered inadvertently or without the intention of providing rescue.

Time frame: 24 hours after end of surgery

The Number of Participants With no Emesis, no Significant Nausea and no Use of Rescue Medication

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.