PTN Pantoprazole Study Closes Enrollment

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 disease (GERD) following administration of an oral dose of pantoprazole.

The PTN pantoprazole study enrolls its first patient

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. 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 is examining the pharmacokinetics of the drug in obese children who require treatment with an acid-modifying agent. The data collected will be compared to existing pharmacokinetic data in non-obese subjects.

The study population includes 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. To learn more about this study, visit clinicaltrials.gov.