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

• Sponsor: University of Texas at Austin (Other)
• Overall Status: Completed
• CT.gov ID: NCT03241030
• Collaborator: (none)
• Enrollment: 102
• Location: 1
• Arms: 2
• Actual Duration (Months): 21.2
• Patients Per Site Per Month: 4.8

Study Details

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
• Actual Enrollment: 102 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: Sep 12, 2017
• Actual Primary Completion Date: Jul 31, 2018
• Actual Study Completion Date: Jun 20, 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 ml/kg [Approximately 60 minutes after medication administration.]

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

Secondary Outcome Measures

1. Number of Participants That Require Intravenous Fluid Administration [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 [6 hours from the time of enrollment]

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

3. Number of Participants With Unscheduled Visits [Approximately 72 hours from ED visit]

   Will call families to find out about any unscheduled visits.

Eligibility Criteria

Criteria

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

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

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 31, 2017

More Information

Publications

None provided.

• Responsible Party: Nidhi Vaidya, Resident, University of Texas at Austin
• ClinicalTrials.gov Identifier: NCT03241030
• Other Study ID Numbers: 2017-06-0024
• First Posted: Aug 7, 2017
• Last Update Posted: Oct 29, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• 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; Acetaminophen; Ibuprofen; Sucralfate

Study Results

Participant Flow

Arm/Group Title	Experimental Group	Placebo Group
Arm/Group Description	Subjects will receive sucralfate Sucralfate: Will receive 20mg/kg/dose up to 1 gram. 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. 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.	Subjects will receive a placebo Placebo: Will received placebo solution of similar quantity to that of the weight based dose of sucralfate. 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. 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.
Period Title: Overall Study
STARTED	50	52
COMPLETED	49	51
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Experimental Group	Placebo Group	Total
Arm/Group Description	Subjects will receive sucralfate Sucralfate: Will receive 20mg/kg/dose up to 1 gram. 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. 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.	Subjects will receive a placebo Placebo: Will received placebo solution of similar quantity to that of the weight based dose of sucralfate. 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. 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.	Total of all reporting groups
Overall Participants	49	51	100
Age (Count of Participants)
<=18 years	49 100%	51 100%	100 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	25 51%	28 54.9%	53 53%
Male	24 49%	23 45.1%	47 47%
Race/Ethnicity, Customized (Count of Participants)
Hispanic	39 79.6%	42 82.4%	81 81%
White	9 18.4%	5 9.8%	14 14%
African American/Black	1 2%	4 7.8%	5 5%

Outcome Measures

1. Primary Outcome

Title	Oral Intake in ml/kg
Description	Will quantify the amount (in ml/kg) of liquid ingested after intervention.
Time Frame	Approximately 60 minutes after medication administration.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental Group	Placebo Group
Arm/Group Description	Subjects will receive sucralfate Sucralfate: Will receive 20mg/kg/dose up to 1 gram. 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. 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.	Subjects will receive a placebo Placebo: Will received placebo solution of similar quantity to that of the weight based dose of sucralfate. 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. 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.
Measure Participants	49	51
Median (Inter-Quartile Range) [oral intake in ml/kg]	9.7	10.7

2. Secondary Outcome

Title	Number of Participants That Require Intravenous Fluid Administration
Description	To explore the difference in the rates of intravenous fluid (IVF) administration in children treated with sucralfate versus placebo.
Time Frame	6 hours from the time of enrollment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental Group	Placebo Group
Arm/Group Description	Subjects will receive sucralfate Sucralfate: Will receive 20mg/kg/dose up to 1 gram. 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. 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.	Subjects will receive a placebo Placebo: Will received placebo solution of similar quantity to that of the weight based dose of sucralfate. 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. 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.
Measure Participants	49	51
Count of Participants [Participants]	5 10.2%	1 2%

3. Secondary Outcome

Title	Number of Participants That Require Admission
Description	To explore the difference in the rates admission rates in children treated with sucralfate versus placebo.
Time Frame	6 hours from the time of enrollment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental Group	Placebo Group
Arm/Group Description	Subjects will receive sucralfate Sucralfate: Will receive 20mg/kg/dose up to 1 gram. 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. 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.	Subjects will receive a placebo Placebo: Will received placebo solution of similar quantity to that of the weight based dose of sucralfate. 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. 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.
Measure Participants	49	51
Count of Participants [Participants]	1 2%	2 3.9%

4. Secondary Outcome

Title	Number of Participants With Unscheduled Visits
Description	Will call families to find out about any unscheduled visits.
Time Frame	Approximately 72 hours from ED visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental Group	Placebo Group
Arm/Group Description	Subjects will receive sucralfate Sucralfate: Will receive 20mg/kg/dose up to 1 gram. 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. 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.	Subjects will receive a placebo Placebo: Will received placebo solution of similar quantity to that of the weight based dose of sucralfate. 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. 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.
Measure Participants	49	51
Count of Participants [Participants]	4 8.2%	6 11.8%

Adverse Events

Time Frame	Until discharge from ED (Average time 3.5 hours)
Arm/Group Title	Experimental Group		Placebo Group
Arm/Group Description	Subjects will receive sucralfate Sucralfate: Will receive 20mg/kg/dose up to 1 gram. 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. 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.		Subjects will receive a placebo Placebo: Will received placebo solution of similar quantity to that of the weight based dose of sucralfate. 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. 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.
All Cause Mortality
	Experimental Group		Placebo Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/49 (0%)		0/51 (0%)
Serious Adverse Events
	Experimental Group		Placebo Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/49 (0%)		0/51 (0%)
Other (Not Including Serious) Adverse Events
	Experimental Group		Placebo Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/49 (0%)		0/51 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.