Amisulpride for Postoperative Nausea and Vomiting

Recruiting at 13 trial locations

Overseen By Gabriel Fox, MB BChir

Age: < 18

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Acacia Pharma Ltd

Must not be taking: Amisulpride, Dexamethasone, Ondansetron, others

Disqualifiers: Transplant, CNS surgery, Corticosteroids, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

410 Participants Needed

Trial Summary

What is the purpose of this trial?

Randomized, double-blind, pediatric trial of amisulpride for prophylaxis of post operative nausea and vomiting

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop all current medications, but you cannot be on regular anti-emetic therapy or certain medications like levodopa. It's best to discuss your current medications with the trial team.

What data supports the effectiveness of the drug Amisulpride Injection [Barhemsys] for treating postoperative nausea and vomiting?

Research shows that intravenous amisulpride is effective in preventing and treating postoperative nausea and vomiting (PONV) in adults. It has been tested in several placebo-controlled trials, demonstrating its usefulness, especially for patients who did not respond to other anti-nausea medications. ^{1 2 3 4 5}

Is intravenous amisulpride safe for humans?

Intravenous amisulpride, used to prevent and treat postoperative nausea and vomiting, has a safety profile similar to a placebo, meaning it generally does not cause significant side effects. ^{1 2 4 5 6}

How is the drug amisulpride unique for treating postoperative nausea and vomiting?

Amisulpride is unique because it is an intravenous drug that acts as a selective dopamine receptor antagonist, making it effective for both preventing and treating postoperative nausea and vomiting, especially in patients who have not responded to other antiemetics. It is particularly useful as a rescue treatment when common prophylactic drugs like 5-HT3 antagonists fail. ^{1 2 3 4 7}

Research Team

Kumar Belani, MD

Principal Investigator

University of Minnesota Masonic Children's Hospital

Eligibility Criteria

This trial is for children from birth to 17 years old who are having non-emergency surgeries like eye surgery, adenotonsillectomy, or otoplasty. They must be healthy enough for anesthesia (ASA I-III) and girls able to have babies must use strong contraception.

Inclusion Criteria

American Society of Anesthesiologists (ASA) risk score I-III

I am 17 years old or younger.

Signed informed consent form and/or assent and willingness of patient and parents to participate in the trial

Exclusion Criteria

I am scheduled for a transplant or brain surgery.

I will need a feeding tube after my surgery.

I am expected to receive corticosteroids for reasons other than preventing nausea.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive IV amisulpride and IV dexamethasone to prevent post-operative nausea and vomiting

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse events and ECG abnormalities

7 days

Continuous monitoring and assessments

Treatment Details

Interventions

• Amisulpride Injection [Barhemsys]

Trial Overview The study tests Amisulpride Injection vs Dexamethasone in preventing sickness after surgery in kids. It's a randomized, double-blind trial meaning neither the doctors nor patients know who gets which treatment.

Participant Groups

Group I: Stage 1 - Group 2: IV amisulpride 0.07 mg/kg + IV dexamethasone Experimental Treatment 2 Interventions

Stage 1 - Group 2: IV amisulpride 0.07 mg/kg + IV dexamethasone

Group II: Stage 1 - Group 1: IV amisulpride 0.035 mg/kg + IV dexamethasone Experimental Treatment 2 Interventions

Stage 1 - Group 1: IV amisulpride 0.035 mg/kg + IV dexamethasone

Amisulpride Injection [Barhemsys] is already approved in United States for the following indications:

Approved in United States as Barhemsys for:

• Prevention of postoperative nausea and vomiting (PONV)
• Treatment of PONV in patients who have received antiemetic prophylaxis with an agent of a different pharmacologic class or have not received prophylaxis

Who Is Running the Clinical Trial?

Acacia Pharma Ltd

Lead Sponsor

Trials

18

Recruited

4,700+

Amicus CD LLC

Collaborator

Trials

1

Recruited

410+

Premier Research Group plc

Industry Sponsor

Trials

65

Recruited

74,200+

John Ratliff

Premier Research Group plc

Chief Executive Officer since 2024

MBA

Dr. Milena Kanova-Petrova

Premier Research Group plc

Chief Medical Officer since 2024

MD

Findings from Research

IV amisulpride is an effective treatment for preventing and treating post-operative nausea and vomiting (PONV) in adults, based on results from phase III trials that showed its efficacy both alone and in combination with other antiemetics.

The safety profile of IV amisulpride is comparable to that of a placebo, indicating it is well-tolerated with no significant safety concerns, making it a valuable option for patients who have not responded to other antiemetic treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Amisulpride: A Review in Post-Operative Nausea and Vomiting. Kang, C., Shirley, M.[2021]

In a study involving 560 surgical patients experiencing postoperative nausea and vomiting (PONV), intravenous amisulpride at doses of 5 and 10 mg significantly improved the complete response rate compared to placebo, with 31.4% of patients in both amisulpride groups achieving no vomiting and not requiring rescue medication.

Amisulpride was found to be safe, with an adverse event profile similar to that of placebo, indicating it can be an effective treatment option for established PONV in patients who did not receive prior prophylaxis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Candiotti, KA., Kranke, P., Bergese, SD., et al.[2023]

In a study involving 702 patients who experienced postoperative nausea or vomiting after surgery, a single 10 mg dose of intravenous amisulpride was found to be significantly more effective than placebo, with a complete response rate of 41.7% compared to 28.5% for placebo.

Amisulpride was shown to be safe, with no clinically relevant toxicities reported, and the incidence of adverse events was similar between amisulpride and placebo groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Amisulpride for the Rescue Treatment of Postoperative Nausea or Vomiting in Patients Failing Prophylaxis: A Randomized, Placebo-controlled Phase III Trial. Habib, AS., Kranke, P., Bergese, SD., et al.[2019]

Intravenous amisulpride has been approved as an effective antiemetic for preventing and treating postoperative nausea and vomiting (PONV), addressing a significant issue in surgical recovery for patients.

The review highlights that amisulpride, with a history of safe use as an oral antipsychotic, can serve as a valuable addition to PONV management, especially for patients who do not respond to standard prophylactic treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pharmacological profile of intravenous amisulpride for the treatment of postoperative nausea and vomiting. Fox, G., Kranke, P.[2022]

In a study involving 689 surgical patients, intravenous amisulpride significantly reduced the incidence of postoperative nausea and vomiting compared to placebo, with a complete response rate of 46.9% in the U.S. trial and 57.4% in the European trial.

Amisulpride was found to have a similar safety profile to placebo, with no significant differences in side effects such as QT prolongation or sedation, indicating it is a safe option for preventing postoperative nausea and vomiting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous Amisulpride for the Prevention of Postoperative Nausea and Vomiting: Two Concurrent, Randomized, Double-blind, Placebo-controlled Trials. Gan, TJ., Kranke, P., Minkowitz, HS., et al.[2018]

In a study of 100 patients undergoing craniotomy, a single preoperative dose of amisulpride significantly reduced the incidence of postoperative nausea (90% vs. 40%) and vomiting (94% vs. 46%) compared to a placebo.

Amisulpride also decreased the severity of nausea in the first 4 hours after surgery and reduced the need for rescue antiemetics, all without increasing the risk of adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Role of Preoperative Oral Amisulpride as Part of a Multimodal Antiemetic Prophylaxis Regime on Postoperative Nausea and Vomiting in Patients Undergoing Craniotomy: A Prospective, Double-Blind, Randomized, Placebo-controlled Study. Gupta, A., Gupta, D., Gupta, P., et al.[2023]

Amisulpride significantly improves the prevention and treatment of postoperative nausea and vomiting (PONV) compared to placebo, with a relative risk of complete response at 1.30 based on a systematic review of five studies involving 3243 patients.

The safety profile of amisulpride is comparable to that of placebo, indicating that low-dose intravenous amisulpride is a safe option for managing PONV, although further research is needed to determine the best dosing and timing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of amisulpride on postoperative nausea and vomiting: a systematic review and meta-analysis. Zhang, LF., Zhang, CF., Tang, WX., et al.[2021]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Amisulpride: A Review in Post-Operative Nausea and Vomiting. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

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. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Amisulpride for the Rescue Treatment of Postoperative Nausea or Vomiting in Patients Failing Prophylaxis: A Randomized, Placebo-controlled Phase III Trial. [2019]

4. England pubmed.ncbi.nlm.nih.gov

A pharmacological profile of intravenous amisulpride for the treatment of postoperative nausea and vomiting. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Intravenous Amisulpride for the Prevention of Postoperative Nausea and Vomiting: Two Concurrent, Randomized, Double-blind, Placebo-controlled Trials. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the Role of Preoperative Oral Amisulpride as Part of a Multimodal Antiemetic Prophylaxis Regime on Postoperative Nausea and Vomiting in Patients Undergoing Craniotomy: A Prospective, Double-Blind, Randomized, Placebo-controlled Study. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

Efficacy of amisulpride on postoperative nausea and vomiting: a systematic review and meta-analysis. [2021]