dan 2163 has been researched along with Emesis, Postoperative in 15 studies
Excerpt | Relevance | Reference |
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"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) |
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
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
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
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
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
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
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
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
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
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
Intervention | minutes (Median) |
---|---|
APD421 5mg | 159 |
APD421 10mg | 177 |
Placebo | 79 |
(NCT01510704)
Timeframe: 24 hours
Intervention | participants (Number) |
---|---|
Placebo | 37 |
Low Dose APD421 | 28 |
Mid Dose APD421 | 20 |
High Dose APD421 | 30 |
4 reviews available for dan 2163 and Emesis, Postoperative
Article | Year |
---|---|
An overview of intravenous amisulpride as a new therapeutic option for the prophylaxis and treatment of postoperative nausea and vomiting.
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.
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.
Topics: Amisulpride; Dopamine Antagonists; Humans; Postoperative Nausea and Vomiting; Randomized Controlled | 2020 |
Amisulpride: A Review in Post-Operative Nausea and Vomiting.
Topics: Amisulpride; Dopamine Antagonists; Humans; Injections, Intravenous; Postoperative Nausea and Vomitin | 2021 |
6 trials available for dan 2163 and Emesis, Postoperative
Article | Year |
---|---|
Intravenous Amisulpride Does Not Meaningfully Prolong the QTc Interval at Doses Effective for the Management of Postoperative Nausea and Vomiting.
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.
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.
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.
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.
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.
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.
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.
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.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Amisulpride; Dopamine Antagonists; Double-Blind Method; | 2017 |
5 other studies available for dan 2163 and Emesis, Postoperative
Article | Year |
---|---|
Amisulpride.
Topics: Adult; Amisulpride; Antiemetics; Dopamine D2 Receptor Antagonists; Humans; Postoperative Nausea and | 2020 |
Amisulpride: A New Drug for Management of Postoperative Nausea and Vomiting.
Topics: Adult; Amisulpride; Antiemetics; Child; Dopamine Antagonists; Humans; Pharmaceutical Preparations; P | 2021 |
IV Amisulpride (Barhemsys) for postoperative nausea and vomiting.
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.
Topics: Amisulpride; Humans; Postoperative Nausea and Vomiting; Vomiting | 2019 |
Amisulpride: A New Dopamine Antagonist for Treatment of Postoperative Nausea and Vomiting.
Topics: Administration, Intravenous; Amisulpride; Dopamine Antagonists; Double-Blind Method; Humans; Postope | 2019 |