Trial · NCT03241030
Sucralfate to Improve Oral Intake in Children With Infectious Oral Ulcers: a Randomized, Double-blind, Placebo-Controlled Trial
NCT03241030, Phase 2, Completed, University of Texas at Austin; results first posted 2021-10-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Sucralfate to Improve Oral Intake in Children With Infectious Oral Ulcers: a Randomized, Double-blind, Placebo-Controlled Trial. Trials, record NCT03241030. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03241030
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sucralfate to Improve Oral Intake in Children With Infectious Oral Ulcers: a Randomized, Double-blind, Placebo-Controlled Trial
- NCT number
- NCT03241030
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 102 participants, actual
- Lead sponsor
- University of Texas at Austin
- Conditions
- Herpangina, Gingivostomatitis, Hand, Foot and Mouth Disease
- Interventions
- Sucralfate, Placebo, Acetaminophen, Ibuprofen
- First posted
- 2017-08-07
- Last updated
- 2021-10-29
- Results first posted
- 2021-10-29
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Oral Intake in ml/kg | Approximately 60 minutes after medication administration. | Will quantify the amount (in ml/kg) of liquid ingested after intervention. |
| Secondary | Number of Participants That Require Intravenous Fluid Administration | 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. |
| Secondary | Number of Participants That Require Admission | 6 hours from the time of enrollment | To explore the difference in the rates admission rates in children treated with sucralfate versus placebo. |
| Secondary | Number of Participants With Unscheduled Visits | Approximately 72 hours from ED visit | Will call families to find out about any unscheduled visits. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Oral Intake in ml/kg | Approximately 60 minutes after medication administration. | oral intake in ml/kg | MEDIAN | |
| SECONDARY | Number of Participants That Require Intravenous Fluid Administration | 6 hours from the time of enrollment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants That Require Admission | 6 hours from the time of enrollment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Unscheduled Visits | Approximately 72 hours from ED visit | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Oral Intake in ml/kg | Experimental Group | 9.7 | Inter-Quartile Range 3.9 to 19.4 | oral intake in ml/kg | |
| Oral Intake in ml/kg | Placebo Group | 10.7 | Inter-Quartile Range 7.2 to 17.1 | oral intake in ml/kg | |
| Number of Participants That Require Intravenous Fluid Administration | Experimental Group | 5 | Participants | ||
| Number of Participants That Require Intravenous Fluid Administration | Placebo Group | 1 | Participants | ||
| Number of Participants That Require Admission | Experimental Group | 1 | Participants | ||
| Number of Participants That Require Admission | Placebo Group | 2 | Participants | ||
| Number of Participants With Unscheduled Visits | Experimental Group | 4 | Participants | ||
| Number of Participants With Unscheduled Visits | Placebo Group | 6 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Experimental Group | 50 | |
| Overall Study | STARTED | Placebo Group | 52 | |
| Overall Study | COMPLETED | Experimental Group | 49 | |
| Overall Study | COMPLETED | Placebo Group | 51 | |
| Overall Study | NOT COMPLETED | Experimental Group | 1 | |
| Overall Study | NOT COMPLETED | Placebo Group | 1 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Experimental Group | 0 | 49 |
| Total, all-cause mortality | Placebo Group | 0 | 51 |
| Total, other adverse events | Experimental Group | 0 | 49 |
| Total, other adverse events | Placebo Group | 0 | 51 |
| Total, serious adverse events | Experimental Group | 0 | 49 |
| Total, serious adverse events | Placebo Group | 0 | 51 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33867179 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Experimental Group vs Placebo Group: Number of Participants That Require Admission | Trial comparisons |
| Experimental Group vs Placebo Group: Number of Participants With Unscheduled Visits | Trial comparisons |
| Experimental Group vs Placebo Group: Number of Participants That Require Intravenous Fluid Administration | Trial comparisons |
| Experimental Group vs Placebo Group: deaths from any cause | Trial comparisons |
| Experimental Group vs Placebo Group: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03241030
GET https://conductscience.org/api/trials/v1/NCT03241030/registered