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Completed

NCT Number: NCT01991821

European Phase III Study of APD421 in PONV

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

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Key information

Conditions

PONV Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU de Hautepierre, Strasbourg, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

APD421

Drug

Placebo

Drug

Primary outcomes

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

    Time frame: 24 hours after end of surgery

    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%.

Secondary outcomes

  1. Complete Response (no Emesis or Rescue Medication)

    Time frame: 24 hrs after end of surgery

  2. Total Response (no Emesis, Nausea or Rescue Medication)

    Time frame: 24 hrs after end of surgery

  3. Incidence of Emesis (Vomiting/Retching)

    Time frame: 24 hours after end of surgeryry

    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

  4. Incidence of Nausea

    Time frame: 24 hours after end of surgery

    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

  5. Incidence of Significant Nausea

    Time frame: 24 hours after end of surgery

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

  6. Use of Rescue Medication

    Time frame: 24 hours after end of surgery

Sponsors and collaborators

Lead sponsor

Acacia Pharma Ltd

Industry

Registry information

Official study title

Randomised, Double-blind, Placebo-controlled Phase III Study of APD421 (Amisulpride for IV Injection) as Prophylaxis Against Post-operative Nausea and Vomiting

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 25, 2013
Registry last updated
Aug 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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