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

NCT03241030 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 2017-06-0024
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Oral Intake in ml/kg

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

  Approximately 60 minutes after medication administration.

Secondary Outcomes (3)

• Number of Participants That Require Intravenous Fluid Administration

  6 hours from the time of enrollment

• Number of Participants That Require Admission

  6 hours from the time of enrollment

• Number of Participants With Unscheduled Visits

  Approximately 72 hours from ED visit

Study Arms (2)

Experimental Group

EXPERIMENTAL

Subjects will receive sucralfate

Drug: Sucralfate; Drug: Acetaminophen; Drug: Ibuprofen

Placebo Group

PLACEBO COMPARATOR

Subjects will receive a placebo

Other: Placebo; Drug: Acetaminophen; Drug: Ibuprofen

Interventions

Sucralfate DRUG

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

Experimental Group

Placebo OTHER

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

Placebo Group

Acetaminophen DRUG

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.

Experimental Group; Placebo Group

Ibuprofen DRUG

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.

Experimental Group; Placebo Group

Eligibility Criteria

• Age: 6 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

Dell Children's Medical Center

Austin, Texas, 78723, United States

Location

Related Publications (1)

• Singh NV, Gabriele GA, Wilkinson MH. Sucralfate as an Adjunct to Analgesia to Improve Oral Intake in Children With Infectious Oral Ulcers: A Randomized, Double-Blind, Placebo-Controlled Trial. Ann Emerg Med. 2021 Sep;78(3):331-339. doi: 10.1016/j.annemergmed.2021.01.019. Epub 2021 Apr 16.

  PMID: 33867179 DERIVED

MeSH Terms

Conditions

Herpangina; Hand, Foot and Mouth Disease

Interventions

Sucralfate; Acetaminophen; Ibuprofen

Condition Hierarchy (Ancestors)

Coxsackievirus Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Infections; Echovirus Infections

Intervention Hierarchy (Ancestors)

Thioglycosides; Sulfur Compounds; Organic Chemicals; Sucrose; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Results Point of Contact

• Title: Nidhi Singh, MD
• Organization: Baylor College of Medicine

nidhi.singh@bcm.edu

832-824-2771

Study Officials

• Nina Vaidya, MD

  UT Dell Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: July 28, 2017
• First Posted: August 7, 2017
• Study Start: September 12, 2017
• Primary Completion: July 31, 2018
• Study Completion: June 20, 2019
• Last Updated: October 29, 2021
• Results First Posted: October 29, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)