Skip to main content
OpenTrials
Completed

NCT Number: NCT02337062

Phase IIIb Study of APD421 in Combination as PONV Prophylaxis

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).

Completed

Looking for future studies?

Notify Me

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

University Hospital, Besançon, France

Loading trial locations.

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
  • 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

Treatment and study plan

APD421

Drug

Placebo

Drug

Primary outcomes

  1. Number of Participants With Complete Response

    Time frame: 24 hours after the end of surgery

    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)

Secondary outcomes

  1. Number of Participants With Emesis

    Time frame: 24 hours after the end of surgery

    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)

  2. Number of Participants Receiving Rescue Medication

    Time frame: 24 hours after the end of surgery

    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

  3. Number of Participants With Any Nausea

    Time frame: 24 hours after the end of surgery

    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.

  4. Number of Participants With Significant Nausea

    Time frame: 24 hours after end of surgery

    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. "Significant nausea" means a score ≥ 4.

  5. Time to First Violation of Criteria for PONV

    Time frame: 24 hours after end of surgery

    Criteria for PONV are any episode of emesis or use of rescue medication in the 24 hours after the 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 Combination Prophylaxis Against Post-operative Nausea and Vomiting in High-risk Patients

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jan 13, 2015
Registry last updated
Mar 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.