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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

Tracking Information
First Submitted Date  ICMJE July 28, 2017
First Posted Date  ICMJE August 7, 2017
Last Update Posted Date October 26, 2017
Actual Study Start Date  ICMJE September 12, 2017
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2017)
Oral Intake in mililiters [ Time Frame: Approximately 60 minutes after ingestion. ]
Will quantify the amount (in milliliters) of liquid ingested after intervention.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2017)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sucralfate to Improve Oral Intake in Children With Infectious Oral Ulcers: a Randomized, Double-blind, Placebo-Controlled Trial
Official Title  ICMJE Sucralfate to Improve Oral Intake in Children With Infectious Oral Ulcers: a Randomized, Double-blind, Placebo-Controlled Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Herpangina
  • Gingivostomatitis
  • Hand, Foot and Mouth Disease
Intervention  ICMJE
  • Drug: Sucralfate
    Will receive 20mg/kg/dose up to 1 gram.
  • 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.
Study Arms  ICMJE
  • Experimental: Experimental Group
    Subjects will receive sucralfate
    Interventions:
    • Drug: Sucralfate
    • Drug: Acetaminophen
    • Drug: Ibuprofen
  • Placebo Comparator: Placebo Group
    Subjects will receive a placebo
    Interventions:
    • Other: Placebo
    • Drug: Acetaminophen
    • Drug: Ibuprofen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 1, 2017)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 5 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03241030
Other Study ID Numbers  ICMJE 2017-06-0024
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Texas at Austin
Study Sponsor  ICMJE University of Texas at Austin
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nina Vaidya, MD UT Dell Medical School
PRS Account University of Texas at Austin
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP