DehydrationPhase 4OSEPNCT01870648
Ondansetron Administration to Children With Gastroenteritis, Vomiting and SOME Dehydration in EDs in Pakistan
A Phase 4 study testing Ondansetron in people with Dehydration and Gastroenteritis, run by Dr. Stephen Freedman at 2 sites in Pakistan.
Trial summary
The primary objective is to determine if the administration of a single dose of oral ondansetron (an anti-vomiting medication), compared to placebo, results in a reduction in intravenous (IV) rehydration therapy in children presenting for emergency department care with some dehydration, vomiting and diarrhea in… Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Dehydration, Gastroenteritis, Vomiting
- What is being tested?
- Ondansetron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 918 participants
- Where
- 2 sitesPakistan
- Study dates
- May 2014to Dec 2017
- Phase
- Phase 4
- 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 6 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 6 - 59 months (0.5 - 5 years)
- Symptoms consistent with gastroenteritis (must have a \& b)
- 1 episode of nonbilious, nonbloody vomiting within the 4 hours preceding triage The requirement for only 1 vomiting episode is based on prior work which similarly required 1 vomiting episode within 4 hours of triage. The later study reported a 17% absolute reduction in the use of IV rehydration. The vast majority of children seeking care and enrolled in the aforementioned study had a significantly greater number of vomiting episodes in the preceding 24 hour (mean >9 episodes).29
- Presence of ≥ 1 episode of diarrhea during the illness We require the presence of only 1 diarrheal stool to enhance our probability of enrolling children with enteritis (as opposed to other diagnoses).
- In fact, of the 8 RCTs performed using antiemetics in children with gastroenteritis in developed countries, only 1 even required the presence of any diarrhea as part of the eligibility criteria (and that study required a single diarrheal stool).
- Presence of "SOME" dehydration - 2 or more of the following signs: i. Restlessness, irritability; ii. Sunken Eyes; iii.Drinks eagerly, thirsty; iv.Skin pinch goes back slowly
Who cannot join
- Weight <8 kg
- Vomiting or diarrhea for > 7 days
- Malnutrition: The WHO definition will be employed - weight for height below -3z scores of the median WHO growth standards
- Severe dehydration (WHO criteria) or hypotension defined as a systolic blood pressure <70 mm Hg in infants 1 month to 12 months, < 70 mm Hg + (2 x age in years) in children 1-10 years, < 90 mm Hg in children ≥ 10 years
- Prior abdominal surgery (excluding hernia)
- Bilious or bloody vomitus
Show all 11Show fewer
- Known hypersensitivity to ondansetron or any serotonin receptor antagonist
- History or family history of prolonged QT syndrome
- Taking apomorphine or any medication that is generally accepted as having a risk of causing torsades de pointes
- Patients previously enrolled in the study
- Follow-up will not be possible
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Aga Khan University Hospital
Karachi
Aga Khan Hospital for Women and Children (AKHWC)
Kharadar, Karachi
About this study
Official title: Ondansetron Administration to Children With Gastroenteritis, Vomiting and SOME Dehydration in Emergency Departments in Pakistan
The primary objective is to determine if the administration of a single dose of oral ondansetron (an anti-vomiting medication), compared to placebo, results in a reduction in intravenous (IV) rehydration therapy in children presenting for emergency department care with some dehydration, vomiting and diarrhea in Pakistan.
SOME Dehydration is defined as 2 or more of the following signs and symptoms:
- Restlessness, irritability
- Sunken Eyes
- Drinks eagerly, thirsty
- Skin pinch goes back slowly
Read the detailed description
Gastroenteritis remains one of the most common causes of morbidity and mortality in children <5 years of age worldwide. A critical factor in the reduction in mortality over the past 30 years has been the introduction of oral rehydration therapy (ORT) for the treatment of dehydration.
However, its use has stagnated in many low- and middle-income countries (LMIC) where many children lack access to alternatives such as intravenous (IV) rehydration. When such children have fluid losses that cannot be replaced orally due to intractable vomiting, death is common. Finding a safe, non-invasive, and effective strategy to reduce vomiting in children would substantially decrease the need for IV rehydration and hence morbidity and mortality in LMICs. Although antiemetic agents are included in the WHO list of Essential Medicines, their use in children with gastroenteritis is not endorsed by the World Health Organization (WHO). Concerns include a lack of evidence that antiemetic agents can improve outcomes and that they are associated with dangerous side effects. However, in high-income settings, studies on ondansetron, an antiemetic agent, have demonstrated that it can reduce vomiting, IV rehydration, and hospitalization. Recent reviews by prominent organizations (e.g. International child Health Review Collaboration; the Committee on the Selection and Use of Essential Medicines) have indicated an interest in ondansetron use in children with gastroenteritis, and they have concluded that further evidence is required. This trial aims to determine if the administration of a single dose of oral ondansetron results in improved outcomes in children brought for emergency department care with vomiting and diarrhea in Pakistan.
Two trials will be conducted under the umbrella of one study. The proposed trials will be identical with the exception of the severity of dehydration at enrollment (either "some" or none "well"). The trials will have the following specific aims:
- To determine, in children 6 - 59 months of age with AGE with vomiting and diarrhea who have "NO" dehydration, if there is a reduction in the proportion of children administered IV rehydration in those who receive oral ondansetron in addition to all WHO standards of care, compared to those receiving an oral placebo in addition to all WHO standards of care.
- To determine, in children 6 - 59 months of age with AGE with vomiting and diarrhea who have "SOME" dehydration, if there is a reduction in the proportion of children administered IV rehydration in those who receive oral ondansetron in addition to all WHO standards of care, compared to those receiving an oral placebo in addition to all WHO standards of care.
IV rehydration is a powerful marker of treatment failure and reducing the need for IV rehydration therapy in either of these 2 groups of children will be viewed as a significant advance by healthcare providers and decision makers. Previous studies of ondansetron have not been conducted in low and middle income countries (LMIC), have been of relatively small sample sizes, have not employed WHO dehydration scales, and have not focused on young children (i.e. <5 years). These will be the first pediatric randomized, double-blind trials, in a LMIC, defining the impact of oral ondansetron administration in children with AGE on the need for IV rehydration. As such therapy is unavailable to a large number of children in LMIC countries, the ability to demonstrate that ondansetron can reduce the use of IV rehydration will provide compelling evidence that this drug has the potential to save lives around the world. We postulate that oral ondansetron administration to children in LMIC, if beneficial in our study population, could serve as a feasible and reliable intervention that is available for provision by non-hospital based, outreach, and healthcare providers in remote regions of the world.
This study may have immediate impact on patient management. Based on the results, it will be discovered if oral ondansetron plays a role in reducing the need for intravenous rehydration in children with gastroenteritis in Pakistan. As ondansetron is now available in generic formulations, and is relatively inexpensive, it is anticipated that if this study is positive, ondansetron will be considered for inclusion in the WHO - gastroenteritis care package. This could ultimately lead to a decrease in the need for intravenous rehydration in children in countries such as Pakistan.
- Conditions
- Dehydration, Gastroenteritis, Vomiting, Diarrhea
- Being tested
- Ondansetron, Placebo
- Keywords
- Low-middle income country, Dehydration, Intravenous Rehydration, Pakistan
- Medical subject headings
- Dehydration, Gastroenteritis, Vomiting, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OndansetronDrug
Also called Zofran
Eligible children will receive one weight based (0.13 - 0.26 mg/kg) dose of an oral ondansetron disintegrating tablet. Subsequent therapy will be in accordance with World Health Organization guidelines as dictated by the child's hydration status.
PlaceboDrug
Also called Sugar Pill
Eligible children will receive one dose of an oral disintegrating Placebo (sugar pill) tablet. Subsequent therapy will be in accordance with World Health Organization guidelines as dictated by the child's hydration status.
| Study group | Role | What they receive |
|---|---|---|
| Ondansetron | Experimental | 4 mg oral disintegrating tablet of ondansetron
Participant weight 8-15 kg = half dose (2mg) Participant weight greater than 15 kg = full dose (4mg) Receives: Drug: Ondansetron |
| Placebo (sugar pill) | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intravenous (IV) Rehydration
IV rehydration is defined as the IV administration of ≥20 ml/kg over 4 hours an isotonic fluid for the purpose of rehydration within 72 hours of randomization. This definition allows for the occurrence of the primary outcome in children who receive maintenance plus replacement of losses and not simply those who receive a fluid bolus. This will not include those who simply receive maintenance fluids (e.g. 4 ml/kg/hr for those weighing < 10 kg). This will also enable us to exclude children who undergo IV insertion for the purpose of medication administration. IV rehydration is a powerful marker of treatment failure, a decrease in which is likely to impact practice and influence decision makers since it is drastically more expensive that ORT, it is painful and is associated with a greater risk of adverse events.
Measured: within 72 hours of randomization
Secondary outcomes (8)
The proportion of children who vomit during the 4 hour observation period
Measured: within 4 hour observation period after randomization
The frequency of vomiting during the 4 hour observation period
Measured: within 4 hour observation period after randomization
Hospitalization > 24 hours
Total length of stay from Emergency Department (ED) arrival until discharge of > 24 hours, regardless of whether time is spent in the ED or inpatient unit
Measured: 72 hours after randomization; 24 hour follow up as needed; chart review 21 days after enrollment
Volume of Oral Rehydration Solution (ORS) consumed (ml/kg) during the 4 hour observation period
Measured: within 4 hour observation period after randomization
Development of "SOME" dehydration during the 72 hours following randomization amongst children who are discharged
All children will be presumed to not be dehydrated at the time of discharge regardless of severity of dehydration at the time of ED presentation.
Measured: within 72 hours of randomization
Number of diarrheal stools during the 72 hours following randomization
Diarrheal stools are defined, in keeping with the WHO definition as "loose or liquid stools"
Measured: within 72 hours of randomization
Treatment failure
This aggregate outcome will include children who experience the following:
- IV rehydration as defined in primary outcome
- Nasogastric rehydration for > 24 hours - this implies a failure of outpatient Oral Rehydration Therapy (ORT)
- Death within 72 hours (from any cause; in or out of hospital)
Measured: 72 hours after randomization; 24 hour follow up as needed; chart review 21 days after enrollment
Response based on infectious etiology (i.e. bacterial vs. viral), duration of illness (i.e. < 48 vs. ≥ 48 hours), and age (< 18 months vs. ≥ 18 months)
Measured: 72 hours after randomization; 24 hour follow up as needed; chart review 21 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2013 (estimated)
- Study startMay 2014
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DehydrationStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 918 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Stephen Freedman
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Thrasher Research Fund, Aga Khan University
- Responsible party
- Sponsor-investigator, Dr. Stephen Freedman, University of Calgary
- Investigators
- Stephen Freedman, MD, Principal investigator, University of CalgaryZulfiqar Bhutta, MD, Principal investigator, Aga Khan University - World Health OrganizationSajid B Soofi, MD, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01870648
- Sponsor's protocol ID
- RSO1026396
- Acronym
- OSEP
- Status last verified
- Feb 2018
- First submitted
- 30 May 2013
- Last updated
- 2 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Freedman SB, Soofi SB, Willan AR, Williamson-Urquhart S, Siddiqui E, Xie J, Dawoud F, Bhutta ZA. Oral Ondansetron Administration to Dehydrated Children in Pakistan: A Randomized Clinical Trial. Pediatrics. 2019 Dec;144(6):e20192161. doi: 10.1542/peds.2019-2161. Epub 2019 Nov 6.
PubMed 31694979
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ondansetron Administration to Children With Gastroenteritis, Vomiting and SOME Dehydration in Emergency Departments in Pakistan
- ClinicalTrials.gov ID
- NCT01870648
- Acronym / sponsor ID
- OSEP / RSO1026396
- Conditions
- Dehydration, Gastroenteritis, Vomiting, Diarrhea
- Keywords
- Low-middle income country, Dehydration, Intravenous Rehydration, Pakistan
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 918 participants (actual)
- Lead sponsor
- Dr. Stephen FreedmanUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Thrasher Research Fund, Aga Khan University
- Study start
- May 2014 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 6 Jun 2013 (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.
The primary objective is to determine if the administration of a single dose of oral ondansetron (an anti-vomiting medication), compared to placebo, results in a reduction in intravenous (IV) rehydration therapy in children presenting for emergency department care with some dehydration, vomiting and diarrhea in Pakistan.
SOME Dehydration is defined as 2 or more of the following signs and symptoms:
- Restlessness, irritability
- Sunken Eyes
- Drinks eagerly, thirsty
- Skin pinch goes back slowly
Detailed description
Gastroenteritis remains one of the most common causes of morbidity and mortality in children <5 years of age worldwide. A critical factor in the reduction in mortality over the past 30 years has been the introduction of oral rehydration therapy (ORT) for the treatment of dehydration.
However, its use has stagnated in many low- and middle-income countries (LMIC) where many children lack access to alternatives such as intravenous (IV) rehydration. When such children have fluid losses that cannot be replaced orally due to intractable vomiting, death is common. Finding a safe, non-invasive, and effective strategy to reduce vomiting in children would substantially decrease the need for IV rehydration and hence morbidity and mortality in LMICs. Although antiemetic agents are included in the WHO list of Essential Medicines, their use in children with gastroenteritis is not endorsed by the World Health Organization (WHO). Concerns include a lack of evidence that antiemetic agents can improve outcomes and that they are associated with dangerous side effects. However, in high-income settings, studies on ondansetron, an antiemetic agent, have demonstrated that it can reduce vomiting, IV rehydration, and hospitalization. Recent reviews by prominent organizations (e.g. International child Health Review Collaboration; the Committee on the Selection and Use of Essential Medicines) have indicated an interest in ondansetron use in children with gastroenteritis, and they have concluded that further evidence is required. This trial aims to determine if the administration of a single dose of oral ondansetron results in improved outcomes in children brought for emergency department care with vomiting and diarrhea in Pakistan.
Two trials will be conducted under the umbrella of one study. The proposed trials will be identical with the exception of the severity of dehydration at enrollment (either "some" or none "well"). The trials will have the following specific aims:
- To determine, in children 6 - 59 months of age with AGE with vomiting and diarrhea who have "NO" dehydration, if there is a reduction in the proportion of children administered IV rehydration in those who receive oral ondansetron in addition to all WHO standards of care, compared to those receiving an oral placebo in addition to all WHO standards of care.
- To determine, in children 6 - 59 months of age with AGE with vomiting and diarrhea who have "SOME" dehydration, if there is a reduction in the proportion of children administered IV rehydration in those who receive oral ondansetron in addition to all WHO standards of care, compared to those receiving an oral placebo in addition to all WHO standards of care.
IV rehydration is a powerful marker of treatment failure and reducing the need for IV rehydration therapy in either of these 2 groups of children will be viewed as a significant advance by healthcare providers and decision makers. Previous studies of ondansetron have not been conducted in low and middle income countries (LMIC), have been of relatively small sample sizes, have not employed WHO dehydration scales, and have not focused on young children (i.e. <5 years). These will be the first pediatric randomized, double-blind trials, in a LMIC, defining the impact of oral ondansetron administration in children with AGE on the need for IV rehydration. As such therapy is unavailable to a large number of children in LMIC countries, the ability to demonstrate that ondansetron can reduce the use of IV rehydration will provide compelling evidence that this drug has the potential to save lives around the world. We postulate that oral ondansetron administration to children in LMIC, if beneficial in our study population, could serve as a feasible and reliable intervention that is available for provision by non-hospital based, outreach, and healthcare providers in remote regions of the world.
This study may have immediate impact on patient management. Based on the results, it will be discovered if oral ondansetron plays a role in reducing the need for intravenous rehydration in children with gastroenteritis in Pakistan. As ondansetron is now available in generic formulations, and is relatively inexpensive, it is anticipated that if this study is positive, ondansetron will be considered for inclusion in the WHO - gastroenteritis care package. This could ultimately lead to a decrease in the need for intravenous rehydration in children in countries such as Pakistan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ondansetron | Experimental | Drug: Ondansetron4 mg oral disintegrating tablet of ondansetron Participant weight 8-15 kg = half dose (2mg) Participant weight greater than 15 kg = full dose (4mg) |
| Placebo (sugar pill) | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age 6 - 59 months (0.5 - 5 years)
- Symptoms consistent with gastroenteritis (must have a \& b)
- In fact, of the 8 RCTs performed using antiemetics in children with gastroenteritis in developed countries, only 1 even required the presence of any diarrhea as part of the eligibility criteria (and that study required a single diarrheal stool).
- Presence of "SOME" dehydration - 2 or more of the following signs: i. Restlessness, irritability; ii. Sunken Eyes; iii.Drinks eagerly, thirsty; iv.Skin pinch goes back slowly
Key exclusion criteria (11 listed)
- Weight <8 kg
- Vomiting or diarrhea for > 7 days
- Malnutrition: The WHO definition will be employed - weight for height below -3z scores of the median WHO growth standards
- Severe dehydration (WHO criteria) or hypotension defined as a systolic blood pressure <70 mm Hg in infants 1 month to 12 months, < 70 mm Hg + (2 x age in years) in children 1-10 years, < 90 mm Hg in children ≥ 10 years
- Prior abdominal surgery (excluding hernia)
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 |
|---|---|---|
| OndansetronAlso: ZofranEligible children will receive one weight based (0.13 - 0.26 mg/kg) dose of an oral ondansetron disintegrating tablet. Subsequent therapy will be in accordance with World Health Organization guidelines as dictated by the child's hydration status. | Drug | Ondansetron |
| PlaceboAlso: Sugar PillEligible children will receive one dose of an oral disintegrating Placebo (sugar pill) tablet. Subsequent therapy will be in accordance with World Health Organization guidelines as dictated by the child's hydration status. | Drug | Placebo (sugar pill) |
Primary outcome
Intravenous (IV) Rehydration
Time frame: within 72 hours of randomization
IV rehydration is defined as the IV administration of ≥20 ml/kg over 4 hours an isotonic fluid for the purpose of rehydration within 72 hours of randomization. This definition allows for the occurrence of the primary outcome in children who receive maintenance plus replacement of losses and not simply those who receive a fluid bolus. This will not include those who simply receive maintenance fluids (e.g. 4 ml/kg/hr for those weighing < 10 kg). This will also enable us to exclude children who undergo IV insertion for the purpose of medication administration. IV rehydration is a powerful marker of treatment failure, a decrease in which is likely to impact practice and influence decision makers since it is drastically more expensive that ORT, it is painful and is associated with a greater risk of adverse events.
8 secondary outcomes
The proportion of children who vomit during the 4 hour observation period
Time frame: within 4 hour observation period after randomization
The frequency of vomiting during the 4 hour observation period
Time frame: within 4 hour observation period after randomization
Hospitalization > 24 hours
Time frame: 72 hours after randomization; 24 hour follow up as needed; chart review 21 days after enrollment
Volume of Oral Rehydration Solution (ORS) consumed (ml/kg) during the 4 hour observation period
Time frame: within 4 hour observation period after randomization
Development of "SOME" dehydration during the 72 hours following randomization amongst children who are discharged
Time frame: within 72 hours of randomization
Number of diarrheal stools during the 72 hours following randomization
Time frame: within 72 hours of randomization
Treatment failure
Time frame: 72 hours after randomization; 24 hour follow up as needed; chart review 21 days after enrollment
Response based on infectious etiology (i.e. bacterial vs. viral), duration of illness (i.e. < 48 vs. ≥ 48 hours), and age (< 18 months vs. ≥ 18 months)
Time frame: 72 hours after randomization; 24 hour follow up as needed; chart review 21 days after enrollment
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 2 Mar 2018.
- Derived from this study: PubMed 31694979Freedman SB, Soofi SB, Willan AR, Williamson-Urquhart S, Siddiqui E, Xie J, Dawoud F, Bhutta ZA. Oral Ondansetron Administration to Dehydrated Children in Pakistan: A Randomized Clinical Trial. Pediatrics. 2019 Dec;144(6):e20192161. doi: 10.1542/peds.2019-2161. Epub 2019 Nov 6.
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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.
Stephen Freedman, MD principal investigator
University of Calgary
Zulfiqar Bhutta, MD principal investigator
Aga Khan University - World Health Organization
Sajid B Soofi, MD principal investigator
Aga Khan University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ondansetron in people with Dehydration and Gastroenteritis, run by Dr. Stephen Freedman at 2 sites in Pakistan.
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 6 inclusion and 11 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 2 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Intravenous (IV) Rehydration (time frame: within 72 hours of randomization). 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 NCT01870648, which also lists 1 linked publication.
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 2 Mar 2018.