Phase 2
Completed N=102
Sucralfate to Improve Oral Intake in Children With Infectious Oral Ulcers: a Randomized, Double-blind, Placebo-Controlled Trial
Herpangina · Gingivostomatitis · Hand, Foot and Mouth Disease
Source: ClinicalTrials.gov NCT03241030 ↗
Enrolled (actual)
102
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcomePrimary: Oral Intake in ml/kg — 9.7; 10.7 oral intake in ml/kg
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Oral Intake in ml/kg |
9.7; 10.7 | — |
| SECONDARY Number of Participants That Require Intravenous Fluid Administration |
5; 1 | — |
| SECONDARY Number of Participants That Require Admission |
1; 2 | — |
| SECONDARY Number of Participants With Unscheduled Visits |
4; 6 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03241030). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.