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COMPLETEDPhase 2NCT03241030

Sucralfate to Improve Oral Intake in Children With Infectious Oral Ulcers: a Randomized, Double-blind, Placebo-Controlled Trial

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 thei...

Lead sponsor: University of Texas at Austin•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

University of Texas at Austin

Age

0 - 5 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•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

Exclusion Criteria

•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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: October 29, 2021Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE2

Enrollment102

Start dateSep 2017

Last updatedOct 29, 2021

Condition

Herpangina Gingivostomatitis Hand, Foot and Mouth Disease

Locations shown

Dell Children's Medical Center

Austin, Texas

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 29, 2021Data synced to Clareo: May 3, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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