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
Overview
- Phase
- Phase 3
- Intervention
- Ondansetron 8 mg ampoule
- Conditions
- Gastroenteritis
- Sponsor
- Genuine Research Center, Egypt
- Enrollment
- 126
- Primary Endpoint
- The proportion of patients experiencing complete control of nausea and vomiting
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
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: 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.
Investigators
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.
Arms & Interventions
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.
Intervention: Ondansetron 8 mg ampoule
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
Intervention: Metoclopramide 10 mg ampoule
Outcomes
Primary Outcomes
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: 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 a rescue anti-emetic medication
Time Frame: 24 hours after receiving the study medication
Assessed as per physician's discretion
The proportion of patients who needed intravenous rehydration
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 Outcomes
- Overall patient's satisfaction with the tolerability of the study medication(24 hours after receiving the study medication)
- The number of adverse events and serious adverse events(24 hours after receiving the study medication)