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NCT01431326 · ClinicalTrials.gov registry record
Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care
A clinical trial, sponsored by Daniel Benjamin.
- Completed
- Registry status
- 3,520
- Enrollment target
NCT01431326: Completed study, sponsored by Daniel Benjamin.
NCT01431326 is a clinical trial that has completed, run by Daniel Benjamin. The registered enrollment target is 3,520 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01431326 has completed, sponsored by Daniel Benjamin.
- COMPLETED
- Registry status
- 3,520 participants
- Enrollment target
Study Summary
Understudied drugs will be administered to children per standard of care as prescribed by their treating caregiver and only biological sample collection during the time of drug administration will be involved. A total of approximately 7000 children aged \<21 years who are receiving these drugs for standard of care will be enrolled and will be followed for up a maximum of 90 days. The goal of this study is to characterize the pharmacokinetics of understudied drugs for which specific dosing recommendations and safety data are lacking. The prescribing of drugs to children will not be part of this protocol. Taking advantage of procedures done as part of routine medical care (i.e. blood draws) this study will serve as a tool to better understand drug exposure in children receiving these drugs per standard of care. The data collected through this initiative will also provide valuable pharmacokinetic and dosing information of drugs in different pediatric age groups as well as special pediatric populations (i.e. obese).
Primary Outcome
As appropriate for each study drug, the following additional PK parameters will be estimated: * maximum concentration (Cmax) * time to achieve maximum concentration (Tmax) * absorption rate constant (ka) * elimination rate constant (kel) * half-life (t1/2) * area under the curve (AUC) Penetration into body fluids will be determined by comparing exposure (i.e. AUC, Cmax) ratios between the body fluid and plasma or comparison of concentrations in paired samples.
Interventions
- DRUG The POPS study is collecting PK data on children prescribed the following drugs of interest per standard of care:
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,520 participants |
| Start Date | 2011-11 |
| Est. Completion | 2019-11 |
What the finished NCT01431326 record still lists
NCT01431326 is an observational study that tracks outcomes without assigning an intervention. Its 3,520 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 1 intervention - of which The POPS study is collecting PK data on children prescribed the following drugs of interest per standard of care: is the first listed.
NCT01431326 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01431326 about?
NCT01431326 is a clinical study titled "Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care". Understudied drugs will be administered to children per standard of care as prescribed by their treating caregiver and only biological sample collection during the time of drug administration will be involved. A total of approximately 7000 children aged \<21 years who are receiving these drugs for s...
What is the current status of trial NCT01431326?
This trial is currently completed. The enrollment target is 3,520 participants. The study started on 2011-11. Estimated completion is 2019-11.
What interventions are being tested in trial NCT01431326?
The interventions under investigation include: The POPS study is collecting PK data on children prescribed the following drugs of interest per standard of care: (DRUG).
Who is sponsoring clinical trial NCT01431326?
This trial is sponsored by Daniel Benjamin, which has 5 total clinical trials registered on ClinicalTrials.gov.
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