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

Tracking Information

• First Submitted Date: July 28, 2017
• First Posted Date: August 7, 2017
• Last Update Posted Date: October 26, 2017
• Actual Study Start Date: September 12, 2017
• Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Sucralfate to Improve Oral Intake in Children With Infectious Oral Ulcers: a Randomized, Double-blind, Placebo-Controlled Trial
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Supportive Care

Condition

• Herpangina
• Gingivostomatitis
• Hand, Foot and Mouth Disease

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: August 1, 2017): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 2019
• Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Months to 5 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03241030
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: University of Texas at Austin
• Study Sponsor: University of Texas at Austin
• Collaborators: Not Provided

Investigators

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

• PRS Account: University of Texas at Austin
• Verification Date: October 2017