NCT03241030

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

Completed Phase 2 Results posted Last updated 29 October 2021

What this trial tests

Phase 2 trial testing Sucralfate in Herpangina in 102 participants. Completed in 20 June 2019.

Timeline

12 September 2017

Primary endpoint
31 July 2018

20 June 2019

Quick facts

Lead sponsor	University of Texas at Austin
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	supportive care
Enrollment	102
Start date	12 September 2017
Primary completion	31 July 2018
Estimated completion	20 June 2019
Sites	1 location across United States

Drugs / interventions tested

• Sucralfate (sucralfate) — full drug profile →
• Placebo
• Acetaminophen (Paracetamol) — full drug profile →
• Ibuprofen (ibuprofen) — full drug profile →

Conditions studied

• Herpangina — all drugs for Herpangina →
• Gingivostomatitis — all drugs for Gingivostomatitis →
• Hand, Foot and Mouth Disease — all drugs for Hand, Foot and Mouth Disease →

Sponsor

University of Texas at Austin

Who can join

Adults 6 Months to 5, any sex, with Herpangina or Gingivostomatitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Oral Intake in ml/kg Primary · Approximately 60 minutes after medication administration.

Will quantify the amount (in ml/kg) of liquid ingested after intervention.

Group	Value	95% CI
Experimental Group	9.7	3.9 – 19.4
Placebo Group	10.7	7.2 – 17.1

Number of Participants That Require Intravenous Fluid Administration Secondary · 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.

Group	Value	95% CI
Experimental Group	5
Placebo Group	1

Number of Participants That Require Admission Secondary · 6 hours from the time of enrollment

To explore the difference in the rates admission rates in children treated with sucralfate versus placebo.

Group	Value	95% CI
Experimental Group	1
Placebo Group	2

Number of Participants With Unscheduled Visits Secondary · Approximately 72 hours from ED visit

Will call families to find out about any unscheduled visits.

Group	Value	95% CI
Experimental Group	4
Placebo Group	6

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.