GastroenteritisPhase 3NCT05876585
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
A Phase 3 study testing Ondansetron 8 mg ampoule and Metoclopramide 10 mg ampoule in people with Gastroenteritis, run by Genuine Research Center, Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gastroenteritis
- What is being tested?
- Ondansetron 8 mg ampoule and Metoclopramide 10 mg ampoule
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 1 Jun 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized, Double-Blinded, Placebo-Controlled, Phase III 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
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.
Read the 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: 1 year 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.
- Conditions
- Gastroenteritis
- Being tested
- Ondansetron 8 mg ampoule, Metoclopramide 10 mg ampoule
- Medical subject headings
- Gastroenteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ondansetron 8 mg ampouleDrug
Also called Danset ampoule
Study drug
Metoclopramide 10 mg ampouleDrug
Also called Primperan
Comparator drug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: Metoclopramide 10 mg ampoule |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients experiencing complete control of nausea and vomiting
Measured by asking the patient hourly to assess their nausea and vomiting.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 hours after receiving the study medication
The proportion of patients who needed intravenous rehydration
Assessed as per physician's discretion
Measured: 24 hours after receiving the study medication
The proportion of patients who needed a rescue anti-emetic medication
Assessed as per physician's discretion
Measured: 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
Measured: 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
Measured: 24 hours after receiving the study medication
Secondary outcomes (2)
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
Measured: 24 hours after receiving the study medication
Overall patient's satisfaction with the tolerability of the study medication
Measured by asking the patient
Measured: 24 hours after receiving the study medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start1 Jun 2025 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for GastroenteritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genuine Research Center, Egypt
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Adwia Pharma, Egypt
- Responsible party
- Sponsor
- Investigators
- Waleed El-Nabawy, MD, Ph.D, Principal investigator, Department of Internal Medicine, Faculty of Medicine, Beni-Suef University, Beni-Suef, EgyptTarek Ibrahim, MD, Principal investigator, Department of Internal Medicine, Faculty of Medicine, Fayoum University, Fayoum, EgyptAhmed Dabour, MD, Ph.D, Principal investigator, Department of Internal Medicine, Faculty of Medicine, Benha University, Benha, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05876585
- Sponsor's protocol ID
- GRC/ADGE/EG/38/III
- Status last verified
- Sep 2024
- First submitted
- 22 Mar 2023
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32584956Chow 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.
PubMed 21694853Diemunsch 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.
PubMed 9389849Domino 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.
PubMed 10357347
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blinded, Placebo-Controlled, Phase III 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
- ClinicalTrials.gov ID
- NCT05876585
- Acronym / sponsor ID
- GRC/ADGE/EG/38/III
- Conditions
- Gastroenteritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Genuine Research Center, EgyptIndustry (pharma, biotech, devices)
- Collaborators
- Adwia Pharma, Egypt
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 25 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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: 1 year 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Ondansetron 8 mg ampoule | Experimental | Drug: Ondansetron 8 mg ampouleA 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 ampoule | Active comparator | Drug: Metoclopramide 10 mg ampouleMetoclopramide 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ondansetron 8 mg ampouleAlso: Danset ampouleStudy drug | Drug | Ondansetron 8 mg ampoule |
| Metoclopramide 10 mg ampouleAlso: PrimperanComparator drug | Drug | Metoclopramide 10 mg ampoule |
Primary outcome
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
2 secondary outcomes
The number of adverse events and serious adverse events
Time frame: 24 hours after receiving the study medication
Overall patient's satisfaction with the tolerability of the study medication
Time frame: 24 hours after receiving the study medication
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Background: PubMed 32584956Cardemil 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.
- Background: PubMed 21694853Chow 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.
- Background: PubMed 9389849Diemunsch 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.
- Background: PubMed 10357347Domino 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.
- Stuempfig ND, Seroy J. Viral Gastroenteritis. \[Updated 2022 Jun 21\]. In: StatPearls \[Internet\]. Treasure Island (FL): StatPearls Publishing; 2022 JanLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
Ahmed Dabour, MD, Ph.D principal investigator
Department of Internal Medicine, Faculty of Medicine, Benha University, Benha, Egypt
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ondansetron 8 mg ampoule and Metoclopramide 10 mg ampoule in people with Gastroenteritis, run by Genuine Research Center, Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohsen Fathallah, MD, Ph.D (+224514516, mohsen.fathallah@grc-me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients experiencing complete control of nausea and vomiting (time frame: 6 hours after receiving the study medication). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05876585, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.