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

October 26, 2021 updated by: Nidhi Vaidya, University of Texas at Austin
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78723
        • Dell Children's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
Subjects will receive sucralfate
Drug: Sucralfate
Will receive 20mg/kg/dose up to 1 gram.
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.
Placebo Comparator: Placebo Group
Subjects will receive a placebo
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.
Other: Placebo
Will received placebo solution of similar quantity to that of the weight based dose of sucralfate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Approximately 60 minutes after medication administration.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants That Require Intravenous Fluid Administration
Time Frame: 6 hours from the time of enrollment
To explore the difference in the rates of intravenous fluid (IVF) administration in children treated with sucralfate versus placebo.
6 hours from the time of enrollment
Number of Participants That Require Admission
Time Frame: 6 hours from the time of enrollment
To explore the difference in the rates admission rates in children treated with sucralfate versus placebo.
6 hours from the time of enrollment
Number of Participants With Unscheduled Visits
Time Frame: Approximately 72 hours from ED visit
Will call families to find out about any unscheduled visits.
Approximately 72 hours from ED visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas at Austin

Investigators

  • Principal Investigator: Nina Vaidya, MD, UT Dell Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2017

Primary Completion (Actual)

July 31, 2018

Study Completion (Actual)

June 20, 2019

Study Registration Dates

First Submitted

July 28, 2017

First Submitted That Met QC Criteria

August 1, 2017

First Posted (Actual)

August 7, 2017

Study Record Updates

Last Update Posted (Actual)

October 29, 2021

Last Update Submitted That Met QC Criteria

October 26, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-06-0024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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