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

NCT03241030 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2021-10-29

Study results available
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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.

Conditions

  • Herpangina
  • Gingivostomatitis
  • Hand, Foot and Mouth Disease

Interventions

DRUG

Sucralfate

Will receive 20mg/kg/dose up to 1 gram.

OTHER

Placebo

Will received placebo solution of similar quantity to that of the weight based dose of sucralfate.

DRUG

Acetaminophen

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.

DRUG

Ibuprofen

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.

Sponsors & Collaborators

  • University of Texas at Austin

    lead OTHER

Principal Investigators

  • Nina Vaidya, MD · UT Dell Medical School

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-12
Primary Completion
2018-07-31
Completion
2019-06-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03241030 on ClinicalTrials.gov