The Effect of Obesity on the Pharmacokinetics of Pantoprazole in Children and Adolescents

Studying the pharmacokinetics of pantoprazole, a stomach acid-suppressing medication often used to manage gastroesophageal reflux disease (GERD), in obese children and adolescents.

Summary

The World Health Organization has called childhood obesity “one of the most serious public health challenges of the 21st century.” The alarming childhood obesity epidemic brings with it increasing need for pediatricians to treat obesity-related diseases (e.g., type II diabetes mellitus, hypertension, hyperlipidemia, gastroesophageal reflux disease [GERD]) that traditionally have not had origins in childhood or adolescence, leading to a critical therapeutic information gap in pediatrics. Given that obese participants are often excluded from clinical trials during the drug development process, little to no information exists regarding the impact of obesity on drug disposition and action or the appropriate dosing of drugs in obese pediatric patients.

Obese children are more frequently diagnosed with GERD than children of normal weight. Proton pump inhibitors, such as pantoprazole, have become key components in the pharmacological management of GERD in pediatrics. In this multicenter, open-label, single-dose study of pantoprazole, the PTN will examine the pharmacokinetics of the drug in obese children who require treatment with an acid-modifying agent. The data collected in this study will be compared to existing pharmacokinetic data in non-obese subjects.

The study population will comprise obese male and female children and adolescents, ranging in age from 6–17 years (inclusive) with the diagnosis of GERD. Approximately 40 participants will be enrolled at up to 3 sites.

OVERVIEW

Status:
Enrollment closed; analysis ongoing

Principal Investigators:
P. Brian Smith, MD, MPH, MHS
Duke Health, Durham, NC

Valentina Shakhnovich, MD
Children’s Mercy Hospital
Kansas City, MO

NEWS

  • PTN Pantoprazole Study Closes Enrollment September 22, 2015 Congratulations to the PTN Pantoprazole Study Team for closing enrollment with 41 subjects. The study goal was to enroll 40 subjects in two age groups. The dedicated team worked hard to keep the study on track and accomplish this goal. The Pantoprazole Study will evaluate the pharmacokinetics of pantoprazole in obese children and adolescents with gastroesophageal reflux ...
  • The PTN pantoprazole study enrolls its first patient July 10, 2014 The PTN study of the effect of obesity on the pharmacokinetics of pantoprazole in children and adolescents has enrolled its first patient. The study team at Arkansas Children’s Hospital (PI Laura James, MD, SC Lee Howard, RN) did the honors. Obese children are more frequently diagnosed with gastroesophageal reflux disease (GERD) than children of normal weight. ...