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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
Sponsor:
Information provided by (Responsible Party):
University of Texas at Austin

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

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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

Resource links provided by the National Library of Medicine

Drug Information available for: Sucralfate

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.




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.



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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

Information from the National Library of Medicine

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


Locations
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United States, Texas
Dell Children's Medical Center
Austin, Texas, United States, 78723
Sponsors and Collaborators
University of Texas at Austin
Investigators
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Principal Investigator: Nina Vaidya, MD UT Dell Medical School
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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

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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:
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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