Ondansetron Oral Solution for Diarrhea

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Stollery Children's Hospital, Edmonton, Canada
Diarrhea+4 More
Ondansetron Oral Solution - Drug
Eligibility
< 18
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether ondansetron is effective for treating vomiting in people with gastroenteritis.

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Eligible Conditions

  • Diarrhea
  • Viral Illness
  • Vomiting
  • Acute Gastroenteritis

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

This trial is evaluating whether Ondansetron Oral Solution will improve 1 primary outcome, 6 secondary outcomes, and 1 other outcome in patients with Diarrhea. Measurement will happen over the course of 168 hours after baseline.

168 hours after baseline
Satisfaction with care: 5 point Likert Scale
Hour 168
Development of moderate to severe disease as defined by the Modified Vesikari Scale (MVS) Score of ≥ 9 following ED evaluation - change in the MVS score between Hour 0 and Hour 168 of the study.
Proportion of participants who require Intravenous (IV) Rehydration
Proportion of participants who require an unscheduled health care visit
Safety Profile of Multiple Doses of Oral Ondansetron
Vomiting Duration
Vomiting Frequency
Vomiting Proportion

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Ondansetron Oral Solution
1 of 2
Placebo Oral Solution
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 1030 total participants across 2 different treatment groups

This trial involves 2 different treatments. Ondansetron Oral Solution is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Ondansetron Oral Solution
Drug
Ondansetron Oral Solution (4mg/5mL solution) - Dose = 0.15mg/kg. One dose every 8 hours (q8h). Six doses over 48 hours.
Placebo Oral Solution
Drug
Compounded Placebo Oral Solution to match experimental arm

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: measured 24, 48, and 168 hours after baseline visit
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly measured 24, 48, and 168 hours after baseline visit for reporting.

Closest Location

Stollery Children's Hospital - Edmonton, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The treating MD has confirmed that the individual has an acute intestinal infectious process. show original
People aged from six months to seventeen years old can use this library. show original
The person has vomited three times or more in the last 24 hours. show original
If you have vomiting and/or diarrheal symptoms that last for less than 72 hours, you likely don't have norovirus and can continue to attend daycare. show original
The research team screened for vomiting by asking participants if they had vomited within the past six hours show original
The patient should receive at least one dose of ondansetron during the current emergency department visit. show original

Patient Q&A Section

What are the signs of vomiting?

"Often nausea and vomiting are not associated externally or internally with any gastrointestinal problem, and can be misreported as a gastrointestinal problem. A history of recurrent vomiting is a typical presenting complaint. It is not uncommon to confuse the nausea and vomiting that precedes the emesis associated with gastrointestinal (GI) pathology, or that occurs, particularly in children, as a sequelae of GI disease affecting other organs, as nausea and vomiting. The most common identifiable cause of nausea and vomiting is motion sickness (the 'Space Ship vertigo'). It is important that the patient and the physician pay vigilant attention to the history of recurrent and recent vomiting, and that clinicians seek other possible causes of nausea and vomiting." - Anonymous Online Contributor

Unverified Answer

What is vomiting?

"In a young person, nausea and vomiting are usually the only symptom of an acute illness, and there are no major problems caused by vomiting. In an elderly person, vomiting can lead to dehydration. Elderly adults need to look for different symptoms when eating together." - Anonymous Online Contributor

Unverified Answer

How many people get vomiting a year in the United States?

"Overall, approximately 3% of people in the USA get vomit more than once a year. Patients' ages, sexes, and races were found to affect the incidence of vomiting. As a result of the increased level of vomiting in the USA, hospitals in the USA would be able to save approximately $8 billion in hospital costs on gastroenteritis-preventative drugs and devices." - Anonymous Online Contributor

Unverified Answer

What causes vomiting?

"The most common causes of vomiting in general are a wide variety of gastrointestinal causes ranging from dehydration to poisoning, which require medical attention. There are many other causes that affect the patient only when they are vomiting, such as gastrointestinal infection, intoxication, or medications." - Anonymous Online Contributor

Unverified Answer

Can vomiting be cured?

"Vomiting is a common, severe medical condition which may be caused more by nausea than vomiting itself. No test or procedure can determine whether or not vomiting is due to nausea. Vomiting is a symptom, which should be treated for nausea. To help with nausea, a doctor or nurse must first diagnose the underlying cause of excessive vomiting. The treatment of nausea, in both paediatric and adult patients, depends on the underlying cause of vomiting." - Anonymous Online Contributor

Unverified Answer

What are common treatments for vomiting?

"People with vomiting disorder can benefit from an approach that incorporates medication options from nausea, migraine, and gastroesophageal reflux disease. The approach emphasizes using pharmacologic and pharmacotherapeutic interventions in addition to the physiologic approach." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets vomiting?

"Approximately 25% of respondents who reported vomiting had a history of vomiting by the age of 11 years, suggesting that some vomiting can begin early in life. A history of childhood earache with regular vomiting does not increase the risk of vomiting. We suspect that the majority of vomiting occurs after the age of 11 years, but this study is limited by its cross-sectional design." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for vomiting?

"Patients should be counseled on the risks of research participation. Patients should have baseline EKG before study enrollment. They should be screened for any medical history that would preclude participation, such as coronary disease. They should be asked to avoid opioids during the study period. They should be counseled on the use of study results to help them make decisions about treatment. These considerations can minimize the risk of research participation in a new-onset, life-threatening or otherwise difficult disease like malignant vomiting." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving ondansetron oral solution?

"Although ondansetron had proven to be effective in reducing gastro-oesophageal reflux in clinical use, we did not find any data on the use of the oral solution regarding its therapeutic and symptomatic effect when the stomach was empty." - Anonymous Online Contributor

Unverified Answer

Does ondansetron oral solution improve quality of life for those with vomiting?

"A single oral spray (20 mg) of ondansetron (Zofran) improved quality of life in all but one of the trial participants. Therefore, ondansetron nasal spray was not included in the pooled analysis of the three trials, since few patients received nasal spray; thus, the use of nasal spray for nausea and emesis was based on a single small randomized pilot study." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating vomiting?

"There have been advances in the treatment of vomiting which will help alleviate the emotional and physical problems that many find themselves experiencing. There are many ways to help your child with vomiting but it will [help you find the best way to handle your young child's discomfort] (https://wellcom.aapm.org/media/articles/view?article=1327&ref=p_8_1_5_1). All children should be involved in treatment plans for the best outcome possible. If you have any questions as to how to handle your child's vomiting, please [contact us (at home or school)](http://finance." - Anonymous Online Contributor

Unverified Answer

Has ondansetron oral solution proven to be more effective than a placebo?

"Ondansetron in a 1.0 mg oral solution significantly and rapidly reduces symptoms of nausea and vomiting without having adverse effects. The effect of ondansetron was similar to that of dimenhydrinate in the reduction of the number of episodes and the intensity of vomiting episodes. However, the number of patients who received ondansetron was considerably greater than that of dimenhydrinate, which raises concerns regarding the feasibility of using the former drug in actual clinical practice." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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