Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2026-01-01 @ 7:59 AM
Study NCT ID:
NCT05424757
Status:
COMPLETED
Last Update Posted:
2025-11-04
First Post:
2022-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Polyethylene Glycol Safety in Children
Sponsor:
Children's Hospital of Philadelphia
Organization:
Study Overview
Official Title:
Quantitative Analysis of Selected PEG 3350 Components and Metabolites in Children's Plasma and Urine
Status:
COMPLETED
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective is to measure levels of selected PEG 3350 components and metabolites in the blood and urine of children who are already taking PEG 3350 compared to children who are not taking PEG 3350.
Changes to medical therapy are not recommended as part of this study.
Changes to medical therapy are not recommended as part of this study.
Detailed Description:
For subjects taking PEG 3350, blood and urine will be collected 1.5 to 4 hours after subjects take PEG 3350.
For subjects who are not taking PEG 3350, the same PEG 3350 components and metabolites will be measured in blood and urine.
PEG 3350 containing medicines from study subjects will be analyzed for the same PEG 3350 components and metabolites.
A stool specimen will be collected for future studies.
Additional data will be obtained from:
* Review of medical records.
* A brief questionnaire.
* Child Behavior Checklist (CBCL) from the Achenbach System of Empirically Based Assessment (for children more than 1.5 years old)
* Bayley-IV Social-Emotional Scale assessment (for children less than 1.5 years old)
For subjects who are not taking PEG 3350, the same PEG 3350 components and metabolites will be measured in blood and urine.
PEG 3350 containing medicines from study subjects will be analyzed for the same PEG 3350 components and metabolites.
A stool specimen will be collected for future studies.
Additional data will be obtained from:
* Review of medical records.
* A brief questionnaire.
* Child Behavior Checklist (CBCL) from the Achenbach System of Empirically Based Assessment (for children more than 1.5 years old)
* Bayley-IV Social-Emotional Scale assessment (for children less than 1.5 years old)
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R01FD005312-01 | FDA | None | https://reporter.nih.gov/quic… | View |