Trial Outcomes & Findings for Sucralfate to Improve Oral Intake in Children With Infectious Oral Ulcers: a Randomized, Double-blind, Placebo-Controlled Trial (NCT NCT03241030)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

102 participants

Primary outcome timeframe

Approximately 60 minutes after medication administration.

Results posted on

2021-10-29

Participant Flow

Participant milestones

Participant milestones
Measure	Experimental Group 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.	Placebo Group 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.
Overall Study STARTED	50	52
Overall Study COMPLETED	49	51
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental Group n=49 Participants 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.	Placebo Group n=51 Participants 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 n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	49 Participants n=5 Participants	51 Participants n=7 Participants	100 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	28 Participants n=7 Participants	53 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	23 Participants n=7 Participants	47 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	39 Participants n=5 Participants	42 Participants n=7 Participants	81 Participants n=5 Participants
Race/Ethnicity, Customized White	9 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants
Race/Ethnicity, Customized African American/Black	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Approximately 60 minutes after medication administration.

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

Outcome measures

Outcome measures
Measure	Experimental Group n=49 Participants 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.	Placebo Group n=51 Participants 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.
Oral Intake in ml/kg	9.7 oral intake in ml/kg Interval 3.9 to 19.4	10.7 oral intake in ml/kg Interval 7.2 to 17.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Experimental Group n=49 Participants 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.	Placebo Group n=51 Participants 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.
Number of Participants That Require Intravenous Fluid Administration	5 Participants	1 Participants

SECONDARY outcome

Timeframe: 6 hours from the time of enrollment

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

Outcome measures

Outcome measures
Measure	Experimental Group n=49 Participants 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.	Placebo Group n=51 Participants 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.
Number of Participants That Require Admission	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Approximately 72 hours from ED visit

Will call families to find out about any unscheduled visits.

Outcome measures

Outcome measures
Measure	Experimental Group n=49 Participants 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.	Placebo Group n=51 Participants 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.
Number of Participants With Unscheduled Visits	4 Participants	6 Participants

Adverse Events

Experimental Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nidhi Singh, MD

Baylor College of Medicine

Phone: 832-824-2771

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place