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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.

Primary Purpose

Gastroenteritis

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Ondansetron 8 mg ampoule
Metoclopramide 10 mg ampoule
Sponsored by
Genuine Research Center, Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroenteritis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female patients aged between 18 and 65 years. Patients diagnosed with acute gastroenteritis visiting the emergency room. Patients considered by the attending physician to need an anti-emetic medication. Patients able and willing to provide written informed consent. Patients able and willing to complete the study procedures including compliance with the requirements and restrictions listed in the consent form. Exclusion Criteria: Pregnant or lactating women. Patients who received an anti-emetic medication during the past 24 hours. History of hypersensitivity to any components of ondansetron or metoclopramide injection. History of hypersensitivity to other selective 5HT3 receptor antagonists. Patients with moderate or severe impairment of hepatic function. Patients with moderate or severe renal impairment. Patients with congenital long QT syndrome. 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. Patients with hypokalemia or hypomagnesemia. Patients with signs of subacute intestinal obstruction. Patients currently using apomorphine hydrochloride. Patients currently using levodopa or dopamine agonists. Patients with gastrointestinal hemorrhage, mechanical obstruction, or gastrointestinal perforation. Patients with a known history of neuroleptic- or metoclopramide-induced tardive dyskinesia. Patients with epilepsy. Patients with Parkinson's disease. Patients with confirmed or suspected pheochromocytoma. Patients with a known history of methemoglobinemia with metoclopramide or NADH-cytochrome b5 reductase deficiency. 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. Patients with any chronic illness or prior treatment which in the opinion of the investigator should preclude participation in the trial. Receipt of an investigational drug within 6 months prior to screening, or active enrolment in another investigational medication or device trial. Inability to understand and cooperate with the investigators or to give valid consent.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Ondansetron 8 mg ampoule

    Metoclopramide 10 mg ampoule

    Arm Description

    A clear, colorless, sterile solution for injection or infusion. Each 1 ml of the solution contains 2 mg of ondansetron as hydrochloride dihydrate.

    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

    Outcomes

    Primary Outcome Measures

    The proportion of patients experiencing complete control of nausea and vomiting
    Measured by asking the patient hourly to assess their nausea and vomiting.
    The proportion of patients experiencing complete control of nausea and vomiting
    Measured by asking the patient hourly to assess their nausea and vomiting.
    The proportions of patients who experienced nausea, vomiting, or retching.
    Measured by asking the patient hourly to assess their nausea, vomiting, or retching.
    The proportions of patients who experienced nausea, vomiting, or retching.
    Measured by asking the patient hourly to assess their nausea, vomiting, or retching.
    The proportion of patients who needed intravenous rehydration
    Assessed as per physician's discretion
    The proportion of patients who needed a rescue anti-emetic medication
    Assessed as per physician's discretion
    The duration of stay at the emergency room before discharge
    The duration from admission to discharge from the emergency room
    Overall patient's and physician's satisfaction with the efficacy of the study medication
    Measured by asking the patient and the physician

    Secondary Outcome Measures

    The number of adverse events and serious adverse events
    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
    Measured by asking the patient

    Full Information

    First Posted
    March 22, 2023
    Last Updated
    May 24, 2023
    Sponsor
    Genuine Research Center, Egypt
    Collaborators
    Adwia Pharma, Egypt
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05876585
    Brief Title
    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.
    Official Title
    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
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2023 (Anticipated)
    Primary Completion Date
    October 2023 (Anticipated)
    Study Completion Date
    October 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Genuine Research Center, Egypt
    Collaborators
    Adwia Pharma, Egypt

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastroenteritis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Model Description
    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).
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    126 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Ondansetron 8 mg ampoule
    Arm Type
    Experimental
    Arm Description
    A clear, colorless, sterile solution for injection or infusion. Each 1 ml of the solution contains 2 mg of ondansetron as hydrochloride dihydrate.
    Arm Title
    Metoclopramide 10 mg ampoule
    Arm Type
    Active Comparator
    Arm Description
    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
    Intervention Type
    Drug
    Intervention Name(s)
    Ondansetron 8 mg ampoule
    Other Intervention Name(s)
    Danset ampoule
    Intervention Description
    Study drug
    Intervention Type
    Drug
    Intervention Name(s)
    Metoclopramide 10 mg ampoule
    Other Intervention Name(s)
    Primperan
    Intervention Description
    Comparator drug
    Primary Outcome Measure Information:
    Title
    The proportion of patients experiencing complete control of nausea and vomiting
    Description
    Measured by asking the patient hourly to assess their nausea and vomiting.
    Time Frame
    6 hours after receiving the study medication
    Title
    The proportion of patients experiencing complete control of nausea and vomiting
    Description
    Measured by asking the patient hourly to assess their nausea and vomiting.
    Time Frame
    24 hours after receiving the study medication
    Title
    The proportions of patients who experienced nausea, vomiting, or retching.
    Description
    Measured by asking the patient hourly to assess their nausea, vomiting, or retching.
    Time Frame
    6 hours hours after receiving the study medication
    Title
    The proportions of patients who experienced nausea, vomiting, or retching.
    Description
    Measured by asking the patient hourly to assess their nausea, vomiting, or retching.
    Time Frame
    24 hours after receiving the study medication
    Title
    The proportion of patients who needed intravenous rehydration
    Description
    Assessed as per physician's discretion
    Time Frame
    24 hours after receiving the study medication
    Title
    The proportion of patients who needed a rescue anti-emetic medication
    Description
    Assessed as per physician's discretion
    Time Frame
    24 hours after receiving the study medication
    Title
    The duration of stay at the emergency room before discharge
    Description
    The duration from admission to discharge from the emergency room
    Time Frame
    From date of admission until the date of discharge, up to 3 hours
    Title
    Overall patient's and physician's satisfaction with the efficacy of the study medication
    Description
    Measured by asking the patient and the physician
    Time Frame
    24 hours after receiving the study medication
    Secondary Outcome Measure Information:
    Title
    The number of adverse events and serious adverse events
    Description
    Comparison between the number of adverse events and serious adverse events reported in the ondansetron 8 mg group and the metoclopramide 10 mg group
    Time Frame
    24 hours after receiving the study medication
    Title
    Overall patient's satisfaction with the tolerability of the study medication
    Description
    Measured by asking the patient
    Time Frame
    24 hours after receiving the study medication

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or female patients aged between 18 and 65 years. Patients diagnosed with acute gastroenteritis visiting the emergency room. Patients considered by the attending physician to need an anti-emetic medication. Patients able and willing to provide written informed consent. Patients able and willing to complete the study procedures including compliance with the requirements and restrictions listed in the consent form. Exclusion Criteria: Pregnant or lactating women. Patients who received an anti-emetic medication during the past 24 hours. History of hypersensitivity to any components of ondansetron or metoclopramide injection. History of hypersensitivity to other selective 5HT3 receptor antagonists. Patients with moderate or severe impairment of hepatic function. Patients with moderate or severe renal impairment. Patients with congenital long QT syndrome. 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. Patients with hypokalemia or hypomagnesemia. Patients with signs of subacute intestinal obstruction. Patients currently using apomorphine hydrochloride. Patients currently using levodopa or dopamine agonists. Patients with gastrointestinal hemorrhage, mechanical obstruction, or gastrointestinal perforation. Patients with a known history of neuroleptic- or metoclopramide-induced tardive dyskinesia. Patients with epilepsy. Patients with Parkinson's disease. Patients with confirmed or suspected pheochromocytoma. Patients with a known history of methemoglobinemia with metoclopramide or NADH-cytochrome b5 reductase deficiency. 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. Patients with any chronic illness or prior treatment which in the opinion of the investigator should preclude participation in the trial. Receipt of an investigational drug within 6 months prior to screening, or active enrolment in another investigational medication or device trial. Inability to understand and cooperate with the investigators or to give valid consent.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohsen Fathallah, MD, Ph.D
    Phone
    +224514516
    Email
    mohsen.fathallah@grc-me.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Baher Mostafa, MD
    Phone
    +224514516
    Email
    baher.mostafa@grc-me.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Waleed El-Nabawy, MD, Ph.D
    Organizational Affiliation
    Department of Internal Medicine, Faculty of Medicine, Beni-Suef University, Beni-Suef, Egypt
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Tarek Ibrahim, MD
    Organizational Affiliation
    Department of Internal Medicine, Faculty of Medicine, Fayoum University, Fayoum, Egypt
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32584956
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    21694853
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    9389849
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    10357347
    Citation
    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.
    Results Reference
    background
    Links:
    URL
    https://www.ncbi.nlm.nih.gov/books/NBK518995/
    Description
    Stuempfig ND, Seroy J. Viral Gastroenteritis. [Updated 2022 Jun 21]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan

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    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.

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