Clinical Trial to Investigate the Efficacy and Safety of Ondansetron (Danset - Adwia) Versus Placebo Plus the Standard of Care in the Treatment of Nausea and Vomiting in Adult Patients With Acute Gastroenteritis

NCT05876585 | Not Yet Recruiting Phase 3

• 1 other identifier: GRC/ADGE/EG/38/III
• Study Type: interventional
• Target: 126
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gastroenteritis

Outcome Measures

Primary Outcomes (8)

• The proportion of patients experiencing complete control of nausea and vomiting

  Measured by asking the patient hourly to assess their nausea and vomiting.

  6 hours after receiving the study medication

• The proportion of patients experiencing complete control of nausea and vomiting

  Measured by asking the patient hourly to assess their nausea and vomiting.

  24 hours after receiving the study medication

• The proportions of patients who experienced nausea, vomiting, or retching.

  Measured by asking the patient hourly to assess their nausea, vomiting, or retching.

  6 hours hours after receiving the study medication

• The proportions of patients who experienced nausea, vomiting, or retching.

  Measured by asking the patient hourly to assess their nausea, vomiting, or retching.

  24 hours after receiving the study medication

• The proportion of patients who needed intravenous rehydration

  Assessed as per physician's discretion

  24 hours after receiving the study medication

• The proportion of patients who needed a rescue anti-emetic medication

  Assessed as per physician's discretion

  24 hours after receiving the study medication

• The duration of stay at the emergency room before discharge

  The duration from admission to discharge from the emergency room

  From date of admission until the date of discharge, up to 3 hours

• Overall patient's and physician's satisfaction with the efficacy of the study medication

  Measured by asking the patient and the physician

  24 hours after receiving the study medication

Secondary Outcomes (2)

• The number of adverse events and serious adverse events

  24 hours after receiving the study medication

• Overall patient's satisfaction with the tolerability of the study medication

  24 hours after receiving the study medication

Study Arms (2)

Ondansetron 8 mg ampoule

EXPERIMENTAL

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

Drug: Ondansetron 8 mg ampoule

Metoclopramide 10 mg ampoule

ACTIVE COMPARATOR

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

Drug: Metoclopramide 10 mg ampoule

Interventions

Ondansetron 8 mg ampoule DRUG

Study drug

Also known as: Danset ampoule

Ondansetron 8 mg ampoule

Metoclopramide 10 mg ampoule DRUG

Comparator drug

Also known as: Primperan

Metoclopramide 10 mg ampoule

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Genuine Research Center, Egypt: lead
• Adwia Pharma, Egypt: collaborator

Related Publications (4)

• 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.

  PMID: 32584956 BACKGROUND

• 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.

  PMID: 21694853 BACKGROUND

• 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.

  PMID: 9389849 BACKGROUND

• 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.

  PMID: 10357347 BACKGROUND

Related Links

• Stuempfig ND, Seroy J. Viral Gastroenteritis. \[Updated 2022 Jun 21\]. In: StatPearls \[Internet\]. Treasure Island (FL): StatPearls Publishing; 2022 Jan

MeSH Terms

Conditions

Gastroenteritis

Interventions

Ondansetron; Metoclopramide

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols

Study Officials

• Waleed El-Nabawy, MD, Ph.D

  Department of Internal Medicine, Faculty of Medicine, Beni-Suef University, Beni-Suef, Egypt

  PRINCIPAL INVESTIGATOR

• Tarek Ibrahim, MD

  Department of Internal Medicine, Faculty of Medicine, Fayoum University, Fayoum, Egypt

  PRINCIPAL INVESTIGATOR

• Ahmed Dabour, MD, Ph.D

  Department of Internal Medicine, Faculty of Medicine, Benha University, Benha, Egypt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohsen Fathallah, MD, Ph.D

CONTACT

+224514516; mohsen.fathallah@grc-me.com

Baher Mostafa, MD

CONTACT

+224514516; baher.mostafa@grc-me.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: May 25, 2023
• Study Start: June 1, 2025
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share