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

• ClinicalTrials.gov Identifier: NCT03241030
• Recruitment Status: Unknown
• First Posted: August 7, 2017
• Last Update Posted: October 26, 2017
• Sponsor: University of Texas at Austin
• Information provided by (Responsible Party): University of Texas at Austin

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Herpangina; Gingivostomatitis; Hand, Foot and Mouth Disease	Drug: Sucralfate; Other: Placebo; Drug: Acetaminophen; Drug: Ibuprofen	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Sucralfate to Improve Oral Intake in Children With Infectious Oral Ulcers: a Randomized, Double-blind, Placebo-Controlled Trial
• Actual Study Start Date: September 12, 2017
• Estimated Primary Completion Date: June 2019
• Estimated Study Completion Date: June 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Experimental Group; Subjects will receive sucralfate	Drug: Sucralfate; Will receive 20mg/kg/dose up to 1 gram.; 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.
Placebo Comparator: Placebo Group; Subjects will receive a placebo	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.

Outcome Measures

Primary Outcome Measures :

1. Oral Intake in mililiters [ Time Frame: Approximately 60 minutes after ingestion. ]
   Will quantify the amount (in milliliters) of liquid ingested after intervention.

Secondary Outcome Measures :

1. Number of participants that require intravenous fluid administration [ Time Frame: 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.
2. Number of participants that require admission [ Time Frame: 6 hours from the time of enrollment ]
   To explore the difference in the rates admission rates in children treated with sucralfate versus placebo.
3. Rates of unscheduled visits [ Time Frame: Approximately 72 hours from ED visit ]
   Will call families to find out about any unscheduled visits.

Eligibility Criteria

• Ages Eligible for Study: 6 Months to 5 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Texas

Dell Children's Medical Center

Austin, Texas, United States, 78723

Sponsors and Collaborators

University of Texas at Austin

Investigators

• Principal Investigator: Nina Vaidya, MD; UT Dell Medical School

More Information

• Responsible Party: University of Texas at Austin
• ClinicalTrials.gov Identifier: NCT03241030
• Other Study ID Numbers: 2017-06-0024
• First Posted: August 7, 2017
• Last Update Posted: October 26, 2017
• Last Verified: October 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Foot-and-Mouth Disease; Hand, Foot and Mouth Disease; Herpangina; Mouth Diseases; Oral Ulcer; Stomatognathic Diseases; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Coxsackievirus Infections; Enterovirus Infections; Echovirus Infections; Acetaminophen; Ibuprofen; Sucralfate; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Antipyretics; Anti-Inflammatory Agents, Non-Steroidal; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anti-Ulcer Agents; Gastrointestinal Agents