HerpanginaPhase 2NCT03241030
Sucralfate to Improve Oral Intake in Children With Infectious Oral Ulcers: a Randomized, Double-blind, Placebo-Controlled Trial
A Phase 2 study testing Sucralfate, Acetaminophen and Ibuprofen in people with Herpangina and Gingivostomatitis, run by University of Texas at Austin at 1 site in United States.
Trial summary
The purpose of this study is to see if sucralfate, a medication commonly used for patients with stomach ulcers, may help pediatric patients with mouth ulcers decrease their pain level and improve their ability to drink. Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Herpangina, Gingivostomatitis, Hand, Foot and Mouth Disease
- What is being tested?
- Sucralfate, Acetaminophen and Ibuprofen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2017to 20 Jun 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age ≥6 months and ≤5 years old
- Present with oral infectious ulcers such as gingivostomatitis, herpangina, or hand, foot and mouth disease
- History of decreased oral fluid intake by parent or guardian
- English or Spanish speaking parents or guardians
Who cannot join
- Severely dehydrated or toxic, requiring immediate resuscitation
- Exclusively breastfed
- Severe dental disease
- Significant mouth trauma
- Active Malignancy
- Preexisting upper airway obstruction or swallowing difficulties
- Received intravenous fluids within 24 hours
- Administration of BOTH acetaminophen AND ibuprofen prior to triage and within 4 hours of enrollment
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to see if sucralfate, a medication commonly used for patients with stomach ulcers, may help pediatric patients with mouth ulcers decrease their pain level and improve their ability to drink.
- Conditions
- Herpangina, Gingivostomatitis, Hand, Foot and Mouth Disease
- Being tested
- Sucralfate, Placebo, Acetaminophen, Ibuprofen
- Medical subject headings
- Herpangina, Hand, Foot and Mouth Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SucralfateDrug
Will receive 20mg/kg/dose up to 1 gram.
PlaceboOther
Will received placebo solution of similar quantity to that of the weight based dose of sucralfate.
AcetaminophenDrug
All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo.
IbuprofenDrug
All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Subjects will receive sucralfate Receives: Drug: Sucralfate; Drug: Acetaminophen; Drug: Ibuprofen |
| Placebo Group | Placebo comparator | Subjects will receive a placebo Receives: Other: Placebo; Drug: Acetaminophen; Drug: Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral Intake in ml/kg
Will quantify the amount (in ml/kg) of liquid ingested after intervention.
Measured: Approximately 60 minutes after medication administration.
Secondary outcomes (3)
Number of Participants That Require Intravenous Fluid Administration
To explore the difference in the rates of intravenous fluid (IVF) administration in children treated with sucralfate versus placebo.
Measured: 6 hours from the time of enrollment
Number of Participants That Require Admission
To explore the difference in the rates admission rates in children treated with sucralfate versus placebo.
Measured: 6 hours from the time of enrollment
Number of Participants With Unscheduled Visits
Will call families to find out about any unscheduled visits.
Measured: Approximately 72 hours from ED visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start12 Sep 2017
- Primary completion31 Jul 2018
- Study completion20 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HerpanginaStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nidhi Vaidya, University of Texas at Austin
- Investigators
- Nina Vaidya, MD, Principal investigator, UT Dell Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03241030
- Sponsor's protocol ID
- 2017-06-0024
- Status last verified
- Oct 2021
- First submitted
- 28 Jul 2017
- Last updated
- 29 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Singh NV, Gabriele GA, Wilkinson MH. Sucralfate as an Adjunct to Analgesia to Improve Oral Intake in Children With Infectious Oral Ulcers: A Randomized, Double-Blind, Placebo-Controlled Trial. Ann Emerg Med. 2021 Sep;78(3):331-339. doi: 10.1016/j.annemergmed.2021.01.019. Epub 2021 Apr 16.
PubMed 33867179
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sucralfate to Improve Oral Intake in Children With Infectious Oral Ulcers: a Randomized, Double-blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT03241030
- Acronym / sponsor ID
- 2017-06-0024
- Conditions
- Herpangina, Gingivostomatitis, Hand, Foot and Mouth Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 12 Sep 2017 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 20 Jun 2019 (actual)
- First posted
- 7 Aug 2017 (actual)
- Results
- Posted 29 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see if sucralfate, a medication commonly used for patients with stomach ulcers, may help pediatric patients with mouth ulcers decrease their pain level and improve their ability to drink.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: Sucralfate, Drug: Acetaminophen, Drug: IbuprofenSubjects will receive sucralfate |
| Placebo Group | Placebo comparator | Other: Placebo, Drug: Acetaminophen, Drug: IbuprofenSubjects will receive a placebo |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age ≥6 months and ≤5 years old
- Present with oral infectious ulcers such as gingivostomatitis, herpangina, or hand, foot and mouth disease
- History of decreased oral fluid intake by parent or guardian
- English or Spanish speaking parents or guardians
Key exclusion criteria (8 listed)
- Severely dehydrated or toxic, requiring immediate resuscitation
- Exclusively breastfed
- Severe dental disease
- Significant mouth trauma
- Active Malignancy
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 |
|---|---|---|
| SucralfateWill receive 20mg/kg/dose up to 1 gram. | Drug | Experimental Group |
| PlaceboWill received placebo solution of similar quantity to that of the weight based dose of sucralfate. | Other | Placebo Group |
| AcetaminophenAll patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo. | Drug | Experimental Group, Placebo Group |
| IbuprofenAll patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo. | Drug | Experimental Group, Placebo Group |
Primary outcome
Oral Intake in ml/kg
Time frame: Approximately 60 minutes after medication administration.
Will quantify the amount (in ml/kg) of liquid ingested after intervention.
3 secondary outcomes
Number of Participants That Require Intravenous Fluid Administration
Time frame: 6 hours from the time of enrollment
Number of Participants That Require Admission
Time frame: 6 hours from the time of enrollment
Number of Participants With Unscheduled Visits
Time frame: Approximately 72 hours from ED visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33867179Singh NV, Gabriele GA, Wilkinson MH. Sucralfate as an Adjunct to Analgesia to Improve Oral Intake in Children With Infectious Oral Ulcers: A Randomized, Double-Blind, Placebo-Controlled Trial. Ann Emerg Med. 2021 Sep;78(3):331-339. doi: 10.1016/j.annemergmed.2021.01.019. Epub 2021 Apr 16.
- 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.
Nina Vaidya, MD principal investigator
UT Dell Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sucralfate, Acetaminophen and Ibuprofen in people with Herpangina and Gingivostomatitis, run by University of Texas at Austin at 1 site in United States.
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 4 inclusion and 8 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 29 Oct 2021. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Oral Intake in ml/kg (time frame: Approximately 60 minutes after medication administration.). 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 NCT03241030, 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 29 Oct 2021.