dan 2163 and Emesis, Postoperative studies

Research Excerpts

Excerpt	Relevance	Reference
"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."	2.90	Amisulpride 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."	2.84	Intravenous 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."	2.66	A 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."	1.62	Amisulpride: A New Drug for Management of Postoperative Nausea and Vomiting. ( Graybill, A; Haber, SL; Minasian, A, 2021)

Research

Studies (15)

Authors

Clinical Trials (4)

Trial Overview

Trial Outcomes

Complete Response (Success of Initial PONV Treatment)

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	0 (0.00)	29.6817
2010's	7 (46.67)	24.3611
2020's	8 (53.33)	2.80

Authors	Studies
Fox, GM	2
Albayaty, M	1
Walker, JL	1
Xue, H	1
Darpo, B	1
Smyla, N	1
Koch, T	1
Eberhart, LH	1
Gehling, M	1
Fox, G	5
Kranke, P	6
Zhang, LF	1
Zhang, CF	1
Tang, WX	1
He, L	1
Liu, Y	1
Tian, DD	1
Ai, YQ	1
Haber, SL	1
Graybill, A	1
Minasian, A	1
Kang, C	1
Shirley, M	1
Bergese, SD	4
Minkowitz, HS	3
Melson, TI	4
Leiman, DG	3
Candiotti, KA	4
Liu, N	2
Eberhart, L	3
Habib, AS	2
Wallenborn, J	2
Kovac, AL	2
Diemunsch, P	5
Gan, TJ	4
Chung, F	2
Ayad, S	1
Siddiqui, N	2
Motsch, J	4
Darvall, JN	1
Leslie, K	1
Mouch, CM	1
Rodriguez, Y	1
Ayad, SS	1
Chassard, D	2
Keh, D	1
Bouaziz, H	1
Bergis, M	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
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 1	30 participants (Actual)	Interventional	2018-07-17	Completed
PROMPT (PONV Rescue Outcomes After Amisulpride Treatment)[NCT04954365]		0 participants (Actual)	Observational [Patient Registry]	2022-11-01	Withdrawn (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 3	568 participants (Actual)	Interventional	2015-09-30	Completed
Randomised, Double-blind, Placebo-controlled, Dose-ranging Phase II Study of APD421 for the Prevention of Post-operative Nausea and Vomiting[NCT01510704]	Phase 2	215 participants (Actual)	Interventional	2012-01-31	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

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

Evolution Score of Nausea (0-30 Mins)

Intervention	Participants (Count of Participants)
APD421 5mg IV	60
APD421 10mg IV	59
Placebo	39

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

Incidence of Nausea

Intervention	Score on a scale*min (Mean)
APD421 5mg	1440.79
APD421 10mg	1502.55
Placebo	1661.25

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

Incidence of Significant Nausea

Intervention	Participants (Count of Participants)
APD421 5mg	151
APD421 10mg	148
Placebo	143

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

Maximum Severity of Nausea

Intervention	Participants (Count of Participants)
APD421 5mg	114
APD421 10mg	108
Placebo	115

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

Number of Participants Using Rescue Medication

Intervention	score on a scale (Mean)
APD421 5mg	4.3
APD421 10mg	4.2
Placebo	4.7

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

Number of Participants With Complete Response 0-2 Hrs

Intervention	Participants (Count of Participants)
APD421 5mg	121
APD421 10mg	119
Placebo	135

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

Number of Participants With Complete Response 2-24 Hrs

Intervention	Participants (Count of Participants)
APD421 5mg	112
APD421 10mg	105
Placebo	79

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

Number of Patients Experiencing Incidence of Emesis

Intervention	Participants (Count of Participants)
APD421 5mg	100
APD421 10mg	109
Placebo	96

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

Time to Treatment Failure

Intervention	Participants (Count of Participants)
APD421 5mg	64
APD421 10mg	57
Placebo	62

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

Article	Year
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

Article	Year
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

Article	Year
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

dan 2163 and Emesis, Postoperative