CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 102 enrolled
Drug / intervention
Sucralfate +3 moredrug
Likely dose
Sucralfate 20mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03241030
NCT03241030Phase 2Completed

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

University of Texas at Austin·interventional·Posted Aug 7, 2017·Updated Oct 29, 2021

In Brief

A Phase 2 clinical trial evaluating Sucralfate, Placebo, and 2 other interventions for Herpangina and 2 related conditions. Completed, enrolled 102 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedAug 7, 2017
Enrollment StartSep 12, 2017
Primary CompletionJul 31, 2018
Study CompletionJun 20, 2019
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 8.9 years ago

Interventions

Sucralfatedrug

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

Placeboother

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

Acetaminophendrug

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.

Ibuprofendrug

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.