Phase 2 N=102 Randomized Quadruple-blind Supportive Care

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

Bottom Line

View on ClinicalTrials.gov: NCT03241030 ↗

Enrolled (actual)

102

Serious AEs

0.0%

Results posted

Oct 2021

Primary outcome: Primary: Oral Intake in ml/kg — 9.7; 10.7 oral intake in ml/kg

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Sucralfate (Drug); Placebo (Other); Acetaminophen (Drug); Ibuprofen (Drug)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: University of Texas at Austin
Primary completion: Jul 2018

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	—

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.

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

View full record on ClinicalTrials.gov →

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.