This Study Will Assess the Efficacy and Safety of Ondansetron Compared to Metoclopramide in the Management of Nausea and Vomiting in Adult Patients With Acute Gastroenteritis.

Overview

A Randomized, Open-label, Active-Controlled Clinical Trial to Investigate the Efficacy and Safety of Ondansetron compared to Metoclopramide in the management of Nausea and Vomiting in Adult Patients with Acute Gastroenteritis.

Full Title of Study: “A Phase III, Randomized, Open-label, Active-controlled, Two-arm, Parallel-design, Interventional Clinical Trial Evaluating the Efficacy and Safety of Ondansetron 8 mg IV/ IM Injection Compared to Metoclopramide 10 mg in the Management of Nausea and Vomiting in Adult Patients With Acute Gastroenteritis”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: None (Open Label)
• Study Primary Completion Date: October 2023

Detailed Description

This is a phase III, randomized, open-label, active-controlled, two-arm, parallel-design, interventional clinical trial evaluating the efficacy and safety of ondansetron 8 mg IV/ IM injection compared to metoclopramide 10 mg in the management of nausea and vomiting in adult patients with acute gastroenteritis. Study duration: 6 months for patients' enrollment and follow-up. Sample Size: 63 subjects per arm, 126 in total. Participants in the trial will be male and female patients aged between 18 and 65 years visiting the emergency room due to acute gastroenteritis. Patients will be screened for eligibility and eligible patients will be randomized in a 1:1 allocation ratio to receive a single dose of ondansetron 8 mg injection (arm 1) or a single dose of metoclopramide 10 mg injection (arm 2). Randomization will be done using interactive web response technology. After drug administration, the patients will be followed up for 24 hours, including at least 3 hours in the emergency room immediately after drug administration.

Interventions

• Drug: Ondansetron 8 mg ampoule
  • Study drug
• Drug: Metoclopramide 10 mg ampoule
  • Comparator drug

Arms, Groups and Cohorts

• Experimental: Ondansetron 8 mg ampoule
  • A clear, colorless, sterile solution for injection or infusion. Each 1 ml of the solution contains 2 mg of ondansetron as hydrochloride dihydrate.
• Active Comparator: Metoclopramide 10 mg ampoule
  • Metoclopramide 10 mg/ 2 ml solution for injection in ampoules. Each 2 ml of the solution contains 10 mg of metoclopramide hydrochloride equivalent to 10 mg of anhydrous metoclopramide

Clinical Trial Outcome Measures

Primary Measures

• The proportion of patients experiencing complete control of nausea and vomiting
  • Time Frame: 6 hours after receiving the study medication
  • Measured by asking the patient hourly to assess their nausea and vomiting.
• The proportion of patients experiencing complete control of nausea and vomiting
  • Time Frame: 24 hours after receiving the study medication
  • Measured by asking the patient hourly to assess their nausea and vomiting.
• The proportions of patients who experienced nausea, vomiting, or retching.
  • Time Frame: 6 hours hours after receiving the study medication
  • Measured by asking the patient hourly to assess their nausea, vomiting, or retching.
• The proportions of patients who experienced nausea, vomiting, or retching.
  • Time Frame: 24 hours after receiving the study medication
  • Measured by asking the patient hourly to assess their nausea, vomiting, or retching.
• The proportion of patients who needed intravenous rehydration
  • Time Frame: 24 hours after receiving the study medication
  • Assessed as per physician’s discretion
• The proportion of patients who needed a rescue anti-emetic medication
  • Time Frame: 24 hours after receiving the study medication
  • Assessed as per physician’s discretion
• The duration of stay at the emergency room before discharge
  • Time Frame: From date of admission until the date of discharge, up to 3 hours
  • The duration from admission to discharge from the emergency room
• Overall patient’s and physician’s satisfaction with the efficacy of the study medication
  • Time Frame: 24 hours after receiving the study medication
  • Measured by asking the patient and the physician

Secondary Measures

• The number of adverse events and serious adverse events
  • Time Frame: 24 hours after receiving the study medication
  • Comparison between the number of adverse events and serious adverse events reported in the ondansetron 8 mg group and the metoclopramide 10 mg group
• Overall patient’s satisfaction with the tolerability of the study medication
  • Time Frame: 24 hours after receiving the study medication
  • Measured by asking the patient

Participating in This Clinical Trial

Inclusion Criteria

1. Male or female patients aged between 18 and 65 years. 2. Patients diagnosed with acute gastroenteritis visiting the emergency room. 3. Patients considered by the attending physician to need an anti-emetic medication. 4. Patients able and willing to provide written informed consent. 5. Patients able and willing to complete the study procedures including compliance with the requirements and restrictions listed in the consent form. Exclusion Criteria:

1. Pregnant or lactating women. 2. Patients who received an anti-emetic medication during the past 24 hours. 3. History of hypersensitivity to any components of ondansetron or metoclopramide injection. 4. History of hypersensitivity to other selective 5HT3 receptor antagonists. 5. Patients with moderate or severe impairment of hepatic function. 6. Patients with moderate or severe renal impairment. 7. Patients with congenital long QT syndrome. 8. Patients who have or may develop prolongation of Qtc, including patients with electrolyte abnormalities, congestive heart failure, bradyarrhythmia, or patients taking other medicinal products that lead to QT prolongation or electrolyte imbalance. 9. Patients with hypokalemia or hypomagnesemia. 10. Patients with signs of subacute intestinal obstruction. 11. Patients currently using apomorphine hydrochloride. 12. Patients currently using levodopa or dopamine agonists. 13. Patients with gastrointestinal hemorrhage, mechanical obstruction, or gastrointestinal perforation. 14. Patients with a known history of neuroleptic- or metoclopramide-induced tardive dyskinesia. 15. Patients with epilepsy. 16. Patients with Parkinson's disease. 17. Patients with confirmed or suspected pheochromocytoma. 18. Patients with a known history of methemoglobinemia with metoclopramide or NADH-cytochrome b5 reductase deficiency. 19. Patients with a history of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment, or compliance with the protocol. 20. Patients with any chronic illness or prior treatment which in the opinion of the investigator should preclude participation in the trial. 21. Receipt of an investigational drug within 6 months prior to screening, or active enrolment in another investigational medication or device trial. 22. Inability to understand and cooperate with the investigators or to give valid consent.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Genuine Research Center, Egypt
• Collaborator
  • Adwia Pharma, Egypt
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Waleed El-Nabawy, MD, Ph.D, Principal Investigator, Department of Internal Medicine, Faculty of Medicine, Beni-Suef University, Beni-Suef, Egypt
  • Tarek Ibrahim, MD, Principal Investigator, Department of Internal Medicine, Faculty of Medicine, Fayoum University, Fayoum, Egypt
• Overall Contact(s)
  • Mohsen Fathallah, MD, Ph.D, +224514516, mohsen.fathallah@grc-me.com

References

Cardemil CV, Balachandran N, Kambhampati A, Grytdal S, Dahl RM, Rodriguez-Barradas MC, Vargas B, Beenhouwer DO, Evangelista KV, Marconi VC, Meagley KL, Brown ST, Perea A, Lucero-Obusan C, Holodniy M, Browne H, Gautam R, Bowen MD, Vinje J, Parashar UD, Hall AJ. Incidence, Etiology, and Severity of Acute Gastroenteritis Among Prospectively Enrolled Patients in 4 Veterans Affairs Hospitals and Outpatient Centers, 2016-2018. Clin Infect Dis. 2021 Nov 2;73(9):e2729-e2738. doi: 10.1093/cid/ciaa806.

Chow CM, Leung AK, Hon KL. Acute gastroenteritis: from guidelines to real life. Clin Exp Gastroenterol. 2010;3:97-112. doi: 10.2147/ceg.s6554. Epub 2010 Jul 15.

Diemunsch P, Conseiller C, Clyti N, Mamet JP. Ondansetron compared with metoclopramide in the treatment of established postoperative nausea and vomiting. The French Ondansetron Study Group. Br J Anaesth. 1997 Sep;79(3):322-6. doi: 10.1093/bja/79.3.322.

Domino KB, Anderson EA, Polissar NL, Posner KL. Comparative efficacy and safety of ondansetron, droperidol, and metoclopramide for preventing postoperative nausea and vomiting: a meta-analysis. Anesth Analg. 1999 Jun;88(6):1370-9. doi: 10.1097/00000539-199906000-00032.