Understudied Drugs for Pediatric Conditions
(POPS or POP02 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how certain drugs act in the bodies of children and young adults to determine the safest and most effective doses. It focuses on medications already prescribed by doctors but not fully studied in younger patients. Participants include children or young adults who are either currently taking one of these understudied drugs as part of their regular care or have tested positive for COVID-19 within the last 60 days. If this applies, the trial could be a suitable fit. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important findings.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. It seems you can continue with your existing medications, especially if they are part of the study drugs of interest.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that the safety of many drugs for children isn't fully understood. These drugs are often used in children without specific safety data, indicating they haven't been studied as extensively in children as in adults. Previous studies, such as those referenced in these trials, aim to understand how these drugs affect children's bodies.
The lack of safety data doesn't imply the drugs are unsafe; it indicates a need to learn more about children's reactions to them. This ongoing research is crucial for determining the safest and most effective doses for young patients.
Although the current study may not yet have specific safety results, it contributes to a larger effort to fill these knowledge gaps and ensure safer treatments for children.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it aims to uncover how understudied drugs behave in children and young adults, especially those who are SARS-CoV-2 positive. The focus is on understanding the pharmacokinetics and pharmacodynamics of these drugs, which means seeing how they move through and affect the body over time. Unlike standard treatments that are well-documented, these understudied drugs could reveal new insights into safer and more effective dosing for young patients. This trial could lead to better-tailored treatments for children, potentially improving their outcomes and minimizing side effects.
Who Is on the Research Team?
Chi Hornik
Principal Investigator
Duke Clinical Research Institute
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive understudied drugs as part of their routine medical care
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Understudied Drugs
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Children and young adults who are prescribed drugs of interest as part of their routine medical care OR are SARS-CoV-2 positive.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Duke University
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
The Emmes Company, LLC
Industry Sponsor
Peter Ronco
The Emmes Company, LLC
Chief Executive Officer since 2023
BSc from Nottingham University
Dr. Joe Sliman
The Emmes Company, LLC
Chief Medical Officer since 2020
MD from Uniformed Services University of the Health Sciences, MPH from Johns Hopkins University, BSc in Molecular and Cell Biology from Pennsylvania State University
Citations
Identifying Pediatric Drug Safety Knowledge Gaps
Drug safety has historically been understudied in pediatric populations, rendering them “therapeutic orphans.” Pediatric drug indications and ...
NCT01431326 | Pharmacokinetics of Understudied Drugs ...
The goal of this study is to characterize the pharmacokinetics of understudied drugs for which specific dosing recommendations and safety data are lacking. The ...
Nonclinical Safety Evaluation of Pediatric Drug Products
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any ...
INTRODUCTION - Doxycycline
To support the safe use of doxycycline in children, the goal of this study was to improve the drug label to include pediatric pharmacokinetic data for children ...
Pharmacokinetics, Pharmacodynamics, and Safety Profile ...
The goal is to characterize the pharmacokinetics of understudied drugs for which specific dosing recommendations and safety data are lacking.
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