Acute GastroenteritisNCT02174874
Ondansetron Oral Versus Orally Disintegrating Tablets (ODT)
An observational study of Acute Gastroenteritis, run by Dr. Graham Thompson at 1 site in Canada.
Trial summary
In children aged 3 months to 10 years who present to the Pediatric Emergency Department (PED) with recent, significant vomiting and moderate dehydration, is treatment with Ondansetron Orally Disintegrating Tablet (ODT) better tolerated than treatment with Ondansetron Oral Solution (OS)? Our hypothesis is that children… Read more about this study
- Who is it for?
- Ages 3 months to 10 years
- Conditions the study is for
- Acute Gastroenteritis
- Type of treatment
- Pill or oral medicine
- How many people
- 462 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2011to Jun 2014
- Phase
- Observational
- 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 3 months to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: Alberta Children's Hospital Emergency department, all patients presenting with acute gastroenteritis
Who may be able to join
- Children aged 3 months to 10 years with recent,
- significant vomiting and moderate dehydration who are managed according to the Alberta Health Services (Calgary and Area) Acute Childhood Vomiting \& Diarrhea Pathway.
- The following definitions are used to determine inclusion according to the pathway: Recent, significant vomiting - Vomiting at least 6 episodes in the past 6 hours and at least once in the past hour; Moderate dehydration (Gorelick Score 2) - Two of the following: capillary refill time greater than 2 seconds, absence of tears, dry mucous membranes, ill general appearance.
Who cannot join
- Children who are excluded from the Alberta Health Services (Calgary and Area) Acute Childhood Vomiting \& Diarrhea Pathway.
- These criteria include: Vomiting or Diarrhea for greater than 7 days, Localized abdominal pain, Chronic medical conditions affecting major organ systems (Ex, diabetes, PKU, immunodeficiency), Likely GI Obstruction (abdominal distension, bilious vomiting, absent bowel sounds), Weight less than 8kg. Children who have received anti-emetics at home will not be excluded but will be tracked.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Ondansetron Oral Solution to Orally Disintegrating Tablets for the Management of Suspected Viral Gastroenteritis in a Pediatric Emergency Department
In children aged 3 months to 10 years who present to the Pediatric Emergency Department (PED) with recent, significant vomiting and moderate dehydration, is treatment with Ondansetron Orally Disintegrating Tablet (ODT) better tolerated than treatment with Ondansetron Oral Solution (OS)? Our hypothesis is that children who receive Ondansetron ODT will have 10% less vomiting within 15 minutes of administration than those receiving Ondansetron OS.
Read the detailed description
Vomiting related to viral gastroenteritis is the most common presentation to the Alberta Children's Hospital Pediatric Emergency Department. Recently, a clinical pathway was implemented to improve the care and flow of patients with vomiting and/or diarrhea through the department. Administration of an antiemetic, Ondansetron, is an integral part of improving the hydration status of children managed by the pathway. However it is not know whether Oral Solution or Oral Disintegrating Tablets are better tolerated in children who have active vomiting. The investigators aim to show that children receiving Oral Disintegrating Tablets have less vomiting immediately after medication administration than children receiving Oral Solution. By demonstrating this improved tolerability the investigators will provide health care providers the stimulus for implementing Ondansetron Oral Disintegrating Tablets into their practice for children with active vomiting.
- Conditions
- Acute Gastroenteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Oral Ondansetron | Arm that receive oral solution .8 mgms per ml ondansetron - Apotex Brand DIN 02291967 | |
| Oral disintegrating tablets | Arm that receives the disintegrating tablets either 4mg or 8 mgs Glaxo Brand 4 mg DIN 02239372, 8 mg DIN 02239373 |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of patients who vomit within 15 minutes of administration of anti-emetic
To determine the proportion of patients aged 3 months to 10 years who present to the PED with recent significant vomiting and moderate dehydration who vomit within 15 minutes of receiving either Ondansetron Oral Solution versus Orally Disintegrating Tablets.
Measured: 15 minutes
Secondary outcomes (2)
# episodes of vomiting after ondansetron administration
To determine the number of episodes of vomiting while in the emergency department (after Ondansetron administration) that are experienced by the above population.
Measured: While in the ED, anticipated to be on average < 5 hours
Discharged home without IV
To determine the proportions of children in each study group that are discharged home from the Emergency Department without receiving IV fluids.
Measured: Duration of ED visit, anticipated to be on average < 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study startJun 2011
- Primary completionMay 2012
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 462 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Graham Thompson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Graham Thompson, Alberta Children's Hospital
- Investigators
- Graham Thompson, Physician, Principal investigator, Alberta Children's Hospital, Department of Pediatrics/Medicine, University of CalgaryDavid W Johnson, Physician, Principal investigator, Alberta Children's Hospital, Department of Pediatrics/Medicine, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02174874
- Sponsor's protocol ID
- OND - 0001
- Status last verified
- Jun 2014
- First submitted
- 26 May 2011
- Last updated
- 26 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ondansetron Oral Solution to Orally Disintegrating Tablets for the Management of Suspected Viral Gastroenteritis in a Pediatric Emergency Department
- ClinicalTrials.gov ID
- NCT02174874
- Acronym / sponsor ID
- OND - 0001
- Conditions
- Acute Gastroenteritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 462 participants (actual)
- Lead sponsor
- Dr. Graham ThompsonUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- May 2012 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 26 Jun 2014 (estimated)
- 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.
In children aged 3 months to 10 years who present to the Pediatric Emergency Department (PED) with recent, significant vomiting and moderate dehydration, is treatment with Ondansetron Orally Disintegrating Tablet (ODT) better tolerated than treatment with Ondansetron Oral Solution (OS)? Our hypothesis is that children who receive Ondansetron ODT will have 10% less vomiting within 15 minutes of administration than those receiving Ondansetron OS.
Detailed description
Vomiting related to viral gastroenteritis is the most common presentation to the Alberta Children's Hospital Pediatric Emergency Department. Recently, a clinical pathway was implemented to improve the care and flow of patients with vomiting and/or diarrhea through the department. Administration of an antiemetic, Ondansetron, is an integral part of improving the hydration status of children managed by the pathway. However it is not know whether Oral Solution or Oral Disintegrating Tablets are better tolerated in children who have active vomiting. The investigators aim to show that children receiving Oral Disintegrating Tablets have less vomiting immediately after medication administration than children receiving Oral Solution. By demonstrating this improved tolerability the investigators will provide health care providers the stimulus for implementing Ondansetron Oral Disintegrating Tablets into their practice for children with active vomiting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Ondansetron | – | –Arm that receive oral solution .8 mgms per ml ondansetron - Apotex Brand DIN 02291967 |
| Oral disintegrating tablets | – | –Arm that receives the disintegrating tablets either 4mg or 8 mgs Glaxo Brand 4 mg DIN 02239372, 8 mg DIN 02239373 |
Who may qualify
- Ages
- 3 months to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Alberta Children's Hospital Emergency department, all patients presenting with acute gastroenteritis
Key inclusion criteria (3 listed)
- Children aged 3 months to 10 years with recent,
- significant vomiting and moderate dehydration who are managed according to the Alberta Health Services (Calgary and Area) Acute Childhood Vomiting \& Diarrhea Pathway.
- The following definitions are used to determine inclusion according to the pathway: Recent, significant vomiting - Vomiting at least 6 episodes in the past 6 hours and at least once in the past hour; Moderate dehydration (Gorelick Score 2) - Two of the following: capillary refill time greater than 2 seconds, absence of tears, dry mucous membranes, ill general appearance.
Key exclusion criteria (2 listed)
- Children who are excluded from the Alberta Health Services (Calgary and Area) Acute Childhood Vomiting \& Diarrhea Pathway.
- These criteria include: Vomiting or Diarrhea for greater than 7 days, Localized abdominal pain, Chronic medical conditions affecting major organ systems (Ex, diabetes, PKU, immunodeficiency), Likely GI Obstruction (abdominal distension, bilious vomiting, absent bowel sounds), Weight less than 8kg. Children who have received anti-emetics at home will not be excluded but will be tracked.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
proportion of patients who vomit within 15 minutes of administration of anti-emetic
Time frame: 15 minutes
To determine the proportion of patients aged 3 months to 10 years who present to the PED with recent significant vomiting and moderate dehydration who vomit within 15 minutes of receiving either Ondansetron Oral Solution versus Orally Disintegrating Tablets.
2 secondary outcomes
# episodes of vomiting after ondansetron administration
Time frame: While in the ED, anticipated to be on average < 5 hours
Discharged home without IV
Time frame: Duration of ED visit, anticipated to be on average < 5 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2014.
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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.
Graham Thompson, Physician principal investigator
Alberta Children's Hospital, Department of Pediatrics/Medicine, University of Calgary
David W Johnson, Physician principal investigator
Alberta Children's Hospital, Department of Pediatrics/Medicine, University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Gastroenteritis, run by Dr. Graham Thompson at 1 site in Canada.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 26 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of patients who vomit within 15 minutes of administration of anti-emetic (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2014.