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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | Subjects will receive sucralfate |
|
| Placebo Group | Placebo Comparator | Subjects will receive a placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sucralfate | Drug | Will receive 20mg/kg/dose up to 1 gram. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Oral Intake in ml/kg | Will quantify the amount (in ml/kg) of liquid ingested after intervention. | Approximately 60 minutes after medication administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants That Require Intravenous Fluid Administration | To explore the difference in the rates of intravenous fluid (IVF) administration in children treated with sucralfate versus placebo. | 6 hours from the time of enrollment |
| Number of Participants That Require Admission |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nina Vaidya, MD | UT Dell Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dell Children's Medical Center | Austin | Texas | 78723 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33867179 | Derived | Singh NV, Gabriele GA, Wilkinson MH. Sucralfate as an Adjunct to Analgesia to Improve Oral Intake in Children With Infectious Oral Ulcers: A Randomized, Double-Blind, Placebo-Controlled Trial. Ann Emerg Med. 2021 Sep;78(3):331-339. doi: 10.1016/j.annemergmed.2021.01.019. Epub 2021 Apr 16. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 31, 2017 |
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| Placebo |
| Other |
Will received placebo solution of similar quantity to that of the weight based dose of sucralfate. |
|
| Acetaminophen | Drug | 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 | Drug | 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. |
|
To explore the difference in the rates admission rates in children treated with sucralfate versus placebo. |
| 6 hours from the time of enrollment |
| Number of Participants With Unscheduled Visits | Will call families to find out about any unscheduled visits. | Approximately 72 hours from ED visit |
| FG001 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Oral Intake in ml/kg | Will quantify the amount (in ml/kg) of liquid ingested after intervention. | Posted | Median | Inter-Quartile Range | oral intake in ml/kg | Approximately 60 minutes after medication administration. |
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| Secondary | Number of Participants That Require Intravenous Fluid Administration | To explore the difference in the rates of intravenous fluid (IVF) administration in children treated with sucralfate versus placebo. | Posted | Count of Participants | Participants | 6 hours from the time of enrollment |
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants That Require Admission | To explore the difference in the rates admission rates in children treated with sucralfate versus placebo. | Posted | Count of Participants | Participants | 6 hours from the time of enrollment |
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Unscheduled Visits | Will call families to find out about any unscheduled visits. | Posted | Count of Participants | Participants | Approximately 72 hours from ED visit |
|
Until discharge from ED (Average time 3.5 hours)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 49 | 0 | 49 | 0 | 49 |
| EG001 | 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. | 0 | 51 | 0 | 51 | 0 | 51 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nidhi Singh, MD | Baylor College of Medicine | 832-824-2771 | nidhi.singh@bcm.edu |
| Oct 26, 2021 |
| Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D006557 | Herpangina |
| D006232 | Hand, Foot and Mouth Disease |
| ID | Term |
|---|---|
| D003384 | Coxsackievirus Infections |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D004457 | Echovirus Infections |
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| ID | Term |
|---|---|
| D013392 | Sucralfate |
| D000082 | Acetaminophen |
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D013865 | Thioglycosides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D013395 | Sucrose |
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D000073893 | Sugars |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
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| >=65 years |
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| Male |
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| White |
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| African American/Black |
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