Sucralfate to Improve Oral Intake in Children With Infectious Oral Ulcers: a Randomized, Double-blind, Placebo-Controlled Trial
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ClinicalTrials.gov Identifier: NCT03241030 |
Recruitment Status : Unknown
Verified October 2017 by University of Texas at Austin.
Recruitment status was: Enrolling by invitation
First Posted : August 7, 2017
Last Update Posted : October 26, 2017
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Condition or disease | Intervention/treatment | Phase |
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Herpangina Gingivostomatitis Hand, Foot and Mouth Disease | Drug: Sucralfate Other: Placebo Drug: Acetaminophen Drug: Ibuprofen | Phase 2 |
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 |

Arm | Intervention/treatment |
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Experimental: Experimental Group
Subjects will receive sucralfate
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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
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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. |
- Oral Intake in mililiters [ Time Frame: Approximately 60 minutes after ingestion. ]Will quantify the amount (in milliliters) of liquid ingested after intervention.
- 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.
- 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.
- Rates of unscheduled visits [ Time Frame: Approximately 72 hours from ED visit ]Will call families to find out about any unscheduled visits.

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Ages Eligible for Study: | 6 Months to 5 Years (Child) |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03241030
United States, Texas | |
Dell Children's Medical Center | |
Austin, Texas, United States, 78723 |
Principal Investigator: | Nina Vaidya, MD | UT Dell Medical School |
Responsible Party: | University of Texas at Austin |
ClinicalTrials.gov Identifier: | NCT03241030 |
Other Study ID Numbers: |
2017-06-0024 |
First Posted: | August 7, 2017 Key Record Dates |
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 |
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 |