Page last updated: 2024-10-22

dan 2163 and Emesis, Postoperative

dan 2163 has been researched along with Emesis, Postoperative in 15 studies

Research Excerpts

ExcerptRelevanceReference
"Of these, 702 patients experienced postoperative nausea or vomiting in the 24-h period after surgery and were randomized to receive a single dose of 5 or 10 mg intravenous amisulpride or matching placebo."2.90Amisulpride for the Rescue Treatment of Postoperative Nausea or Vomiting in Patients Failing Prophylaxis: A Randomized, Placebo-controlled Phase III Trial. ( Ayad, S; Bergese, SD; Candiotti, KA; Chung, F; Diemunsch, P; Fox, GM; Habib, AS; Kranke, P; Leiman, DG; Melson, TI; Motsch, J; Siddiqui, N, 2019)
"Across the two studies, 689 patients were randomized and dosed with study medication, of whom 626 were evaluable per protocol."2.84Intravenous Amisulpride for the Prevention of Postoperative Nausea and Vomiting: Two Concurrent, Randomized, Double-blind, Placebo-controlled Trials. ( Bergese, SD; Candiotti, KA; Chassard, D; Diemunsch, P; Eberhart, L; Fox, G; Gan, TJ; Kovac, AL; Kranke, P; Leiman, DG; Melson, TI; Minkowitz, HS; Motsch, J, 2017)
"The issue of postoperative nausea and vomiting (PONV) remains important in surgical practice, contributing to patient distress, slower recovery, and increased use of healthcare resources."2.66A pharmacological profile of intravenous amisulpride for the treatment of postoperative nausea and vomiting. ( Fox, G; Kranke, P, 2020)
"In 2 trials on the treatment of PONV, a significantly greater percentage of patients who received amisulpride 10 mg compared with placebo experienced a complete response (31."1.62Amisulpride: A New Drug for Management of Postoperative Nausea and Vomiting. ( Graybill, A; Haber, SL; Minasian, A, 2021)

Research

Studies (15)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's0 (0.00)29.6817
2010's7 (46.67)24.3611
2020's8 (53.33)2.80

Authors

AuthorsStudies
Fox, GM2
Albayaty, M1
Walker, JL1
Xue, H1
Darpo, B1
Smyla, N1
Koch, T1
Eberhart, LH1
Gehling, M1
Fox, G5
Kranke, P6
Zhang, LF1
Zhang, CF1
Tang, WX1
He, L1
Liu, Y1
Tian, DD1
Ai, YQ1
Haber, SL1
Graybill, A1
Minasian, A1
Kang, C1
Shirley, M1
Bergese, SD4
Minkowitz, HS3
Melson, TI4
Leiman, DG3
Candiotti, KA4
Liu, N2
Eberhart, L3
Habib, AS2
Wallenborn, J2
Kovac, AL2
Diemunsch, P5
Gan, TJ4
Chung, F2
Ayad, S1
Siddiqui, N2
Motsch, J4
Darvall, JN1
Leslie, K1
Mouch, CM1
Rodriguez, Y1
Ayad, SS1
Chassard, D2
Keh, D1
Bouaziz, H1
Bergis, M1

Clinical Trials (4)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Randomised, Double-blind, Placebo-controlled, Crossover Study in Healthy Adult Subjects to Investigate the Effect of Intravenous APD421, With and Without Ondansetron, on Cardiac Conduction[NCT03583489]Phase 130 participants (Actual)Interventional2018-07-17Completed
PROMPT (PONV Rescue Outcomes After Amisulpride Treatment)[NCT04954365]0 participants (Actual)Observational [Patient Registry]2022-11-01Withdrawn (stopped due to Sponsor terminated prior to initiation.)
Randomised, Double-blind, Placebo-controlled Study of APD421 (Amisulpride for IV Injection) as Treatment of Established Post-operative Nausea and Vomiting, in Patients Who Have Had no Prior Prophylaxis[NCT02449291]Phase 3568 participants (Actual)Interventional2015-09-30Completed
Randomised, Double-blind, Placebo-controlled, Dose-ranging Phase II Study of APD421 for the Prevention of Post-operative Nausea and Vomiting[NCT01510704]Phase 2215 participants (Actual)Interventional2012-01-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Complete Response (Success of Initial PONV Treatment)

The primary efficacy variable was the dichotomous variable: success or failure of initial PONV treatment, where success is defined as no emetic episodes (vomiting or retching) from 30 minutes* to 24 hours after administration of study medication and no administration of anti-emetic rescue medication at any time in the 24-hour period after administration of study medication. (NCT02449291)
Timeframe: 0-24 hours after treatment

InterventionParticipants (Count of Participants)
APD421 5mg IV60
APD421 10mg IV59
Placebo39

Evolution Score of Nausea (0-30 Mins)

The evolution score of nausea was calculated as the area under the curve (AUC) of the nausea scores on a scale 0-10 (where 0 is no nausea and 10 is the worst nausea imaginable) obtained at four pre-planned time points: pre-dose (0-min), and 5, 15 and 30 minutes after administration of study medication, as well as any spontaneously reported episodes of nausea during the time period, plotted against time. A higher score represents a worse outcome. (NCT02449291)
Timeframe: 0-30 minutes after study drug administration

InterventionScore on a scale*min (Mean)
APD421 5mg1440.79
APD421 10mg1502.55
Placebo1661.25

Incidence of Nausea

Proportion of patients with nausea score ≥1 on an 11-point verbal rating scale (0=no nausea, 10=worst possible nausea, therefore higher value is worse outcome) during the time period from 30 minutes to 24 hours after administration of study medication. (NCT02449291)
Timeframe: 30 mins to 24 hours after study drug administration

InterventionParticipants (Count of Participants)
APD421 5mg151
APD421 10mg148
Placebo143

Incidence of Significant Nausea

Proportion of patients with nausea score ≥4 on an 11-point verbal rating scale (0=no nausea, 10=worst possible nausea, therefore higher value is worse outcome) during the time period from 30 minutes to 24 hours after administration of study medication. (NCT02449291)
Timeframe: 30 mins to 24 hours after study drug administration

InterventionParticipants (Count of Participants)
APD421 5mg114
APD421 10mg108
Placebo115

Maximum Severity of Nausea

Highest recorded nausea score on an 11-point verbal rating scale (0=no nausea, 10=worst possible nausea, therefore higher value is worse outcome) during the time period from 30 minutes to 24 hours after administration of study medication. (NCT02449291)
Timeframe: 30 mins to 24 hours after study drug administration

Interventionscore on a scale (Mean)
APD421 5mg4.3
APD421 10mg4.2
Placebo4.7

Number of Participants Using Rescue Medication

Proportion of patients receiving pre-specified anti-emetic rescue medication at any time in the 24 hours post-treatment period (NCT02449291)
Timeframe: 0-24 hours after study drug administration

InterventionParticipants (Count of Participants)
APD421 5mg121
APD421 10mg119
Placebo135

Number of Participants With Complete Response 0-2 Hrs

Success of initial PONV treatment, where success is defined as no emetic episodes (vomiting or retching) from 30 minutes to 2 hours after administration of study medication and no administration of anti-emetic rescue medication at any time in the 2-hour period after administration of study medication. (NCT02449291)
Timeframe: 0-2 hours after administration of study medication

InterventionParticipants (Count of Participants)
APD421 5mg112
APD421 10mg105
Placebo79

Number of Participants With Complete Response 2-24 Hrs

Success of initial PONV treatment, where success is defined as no emetic episodes (vomiting or retching) and no administration of anti-emetic rescue medication from 2 to 24 hours after administration of study medication. (NCT02449291)
Timeframe: 2-24 hours after administration of study medication

InterventionParticipants (Count of Participants)
APD421 5mg100
APD421 10mg109
Placebo96

Number of Patients Experiencing Incidence of Emesis

Number of patients experiencing vomiting or retching during the time period from 30 minutes to 24 hours after administration of study medication (NCT02449291)
Timeframe: 30 mins to 24 hours after study drug administration

InterventionParticipants (Count of Participants)
APD421 5mg64
APD421 10mg57
Placebo62

Time to Treatment Failure

Time to first violation of the criteria for complete response (NCT02449291)
Timeframe: 0-24 hours after study drug administration

Interventionminutes (Median)
APD421 5mg159
APD421 10mg177
Placebo79

Post-operative Nausea or Vomiting

(NCT01510704)
Timeframe: 24 hours

Interventionparticipants (Number)
Placebo37
Low Dose APD42128
Mid Dose APD42120
High Dose APD42130

Reviews

4 reviews available for dan 2163 and Emesis, Postoperative

ArticleYear
An overview of intravenous amisulpride as a new therapeutic option for the prophylaxis and treatment of postoperative nausea and vomiting.
    Expert opinion on pharmacotherapy, 2020, Volume: 21, Issue:5

    Topics: Administration, Intravenous; Amisulpride; Antiemetics; Cost-Benefit Analysis; Dopamine Antagonists;

2020
A pharmacological profile of intravenous amisulpride for the treatment of postoperative nausea and vomiting.
    Expert review of clinical pharmacology, 2020, Volume: 13, Issue:4

    Topics: Administration, Intravenous; Amisulpride; Animals; Antiemetics; Humans; Postoperative Nausea and Vom

2020
Efficacy of amisulpride on postoperative nausea and vomiting: a systematic review and meta-analysis.
    European journal of clinical pharmacology, 2020, Volume: 76, Issue:7

    Topics: Amisulpride; Dopamine Antagonists; Humans; Postoperative Nausea and Vomiting; Randomized Controlled

2020
Amisulpride: A Review in Post-Operative Nausea and Vomiting.
    Drugs, 2021, Volume: 81, Issue:3

    Topics: Amisulpride; Dopamine Antagonists; Humans; Injections, Intravenous; Postoperative Nausea and Vomitin

2021

Trials

6 trials available for dan 2163 and Emesis, Postoperative

ArticleYear
Intravenous Amisulpride Does Not Meaningfully Prolong the QTc Interval at Doses Effective for the Management of Postoperative Nausea and Vomiting.
    Anesthesia and analgesia, 2021, Volume: 132, Issue:1

    Topics: Administration, Intravenous; Adolescent; Adult; Aged; Amisulpride; Cross-Over Studies; Disease Manag

2021
Amisulpride Prevents Postoperative Nausea and Vomiting in Patients at High Risk: A Randomized, Double-blind, Placebo-controlled Trial.
    Anesthesiology, 2018, Volume: 128, Issue:6

    Topics: Administration, Intravenous; Adult; Amisulpride; Anesthesia, General; Antipsychotic Agents; Dopamine

2018
Amisulpride for the Rescue Treatment of Postoperative Nausea or Vomiting in Patients Failing Prophylaxis: A Randomized, Placebo-controlled Phase III Trial.
    Anesthesiology, 2019, Volume: 130, Issue:2

    Topics: Adolescent; Adult; Aged; Aged, 80 and over; Amisulpride; Canada; Dopamine Antagonists; Dose-Response

2019
Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Amisulpride as Treatment of Established Postoperative Nausea and Vomiting in Patients Who Have Had No Prior Prophylaxis.
    Anesthesia and analgesia, 2019, Volume: 128, Issue:6

    Topics: Adult; Aged; Amisulpride; Antiemetics; Canada; Dopamine Antagonists; Double-Blind Method; Female; Fr

2019
Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Amisulpride as Treatment of Established Postoperative Nausea and Vomiting in Patients Who Have Had No Prior Prophylaxis.
    Anesthesia and analgesia, 2019, Volume: 128, Issue:6

    Topics: Adult; Aged; Amisulpride; Antiemetics; Canada; Dopamine Antagonists; Double-Blind Method; Female; Fr

2019
Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Amisulpride as Treatment of Established Postoperative Nausea and Vomiting in Patients Who Have Had No Prior Prophylaxis.
    Anesthesia and analgesia, 2019, Volume: 128, Issue:6

    Topics: Adult; Aged; Amisulpride; Antiemetics; Canada; Dopamine Antagonists; Double-Blind Method; Female; Fr

2019
Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Amisulpride as Treatment of Established Postoperative Nausea and Vomiting in Patients Who Have Had No Prior Prophylaxis.
    Anesthesia and analgesia, 2019, Volume: 128, Issue:6

    Topics: Adult; Aged; Amisulpride; Antiemetics; Canada; Dopamine Antagonists; Double-Blind Method; Female; Fr

2019
I.V. APD421 (amisulpride) prevents postoperative nausea and vomiting: a randomized, double-blind, placebo-controlled, multicentre trial.
    British journal of anaesthesia, 2013, Volume: 111, Issue:6

    Topics: Adult; Aged; Aged, 80 and over; Amisulpride; Anesthesia, Inhalation; Antiemetics; Dopamine Antagonis

2013
Intravenous Amisulpride for the Prevention of Postoperative Nausea and Vomiting: Two Concurrent, Randomized, Double-blind, Placebo-controlled Trials.
    Anesthesiology, 2017, Volume: 126, Issue:2

    Topics: Adolescent; Adult; Aged; Aged, 80 and over; Amisulpride; Dopamine Antagonists; Double-Blind Method;

2017

Other Studies

5 other studies available for dan 2163 and Emesis, Postoperative

ArticleYear
Amisulpride.
    American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists, 2020, Nov-16, Volume: 77, Issue:23

    Topics: Adult; Amisulpride; Antiemetics; Dopamine D2 Receptor Antagonists; Humans; Postoperative Nausea and

2020
Amisulpride: A New Drug for Management of Postoperative Nausea and Vomiting.
    The Annals of pharmacotherapy, 2021, Volume: 55, Issue:10

    Topics: Adult; Amisulpride; Antiemetics; Child; Dopamine Antagonists; Humans; Pharmaceutical Preparations; P

2021
IV Amisulpride (Barhemsys) for postoperative nausea and vomiting.
    The Medical letter on drugs and therapeutics, 2020, 12-28, Volume: 62, Issue:1614

    Topics: Administration, Intravesical; Amisulpride; Antiemetics; Double-Blind Method; Humans; Postoperative N

2020
Pounds of Prevention but Only Ounces of Cure: The Need for More Research on the Treatment of Postoperative Nausea and Vomiting.
    Anesthesiology, 2019, Volume: 130, Issue:2

    Topics: Amisulpride; Humans; Postoperative Nausea and Vomiting; Vomiting

2019
Amisulpride: A New Dopamine Antagonist for Treatment of Postoperative Nausea and Vomiting.
    Anesthesia and analgesia, 2019, Volume: 128, Issue:6

    Topics: Administration, Intravenous; Amisulpride; Dopamine Antagonists; Double-Blind Method; Humans; Postope

2019