NCT03241030

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: University of Texas at Austin · Academic / Other
• Sex: All
• Age: 6 Months – 5 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2017-09-12
• Primary completion: 2018-07-31
• Completion: 2019-06-20
• First posted: 2017-08-07
• Last updated: 2021-10-29
• Results posted: 2021-10-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study