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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03241030
Other study ID # 2017-06-0024
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date September 12, 2017
Est. completion date June 20, 2019

Study information

Verified date October 2021
Source University of Texas at Austin
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 102
Est. completion date June 20, 2019
Est. primary completion date July 31, 2018
Accepts healthy volunteers No
Gender All
Age group 6 Months to 5 Years
Eligibility 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 Design


Intervention

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.
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.

Locations

Country Name City State
United States Dell Children's Medical Center Austin Texas

Sponsors (1)

Lead Sponsor Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Oral Intake in ml/kg Will quantify the amount (in ml/kg) of liquid ingested after intervention. Approximately 60 minutes after medication administration.
Secondary Number of Participants That Require Intravenous Fluid Administration 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
Secondary Number of Participants That Require Admission To explore the difference in the rates admission rates in children treated with sucralfate versus placebo. 6 hours from the time of enrollment
Secondary Number of Participants With Unscheduled Visits Will call families to find out about any unscheduled visits. Approximately 72 hours from ED visit
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