Safety and Efficacy of Nexium in Pediatric Patients with Erosive Esophagitis
Full IRB Study Title:
A Phase III Study to Assess the Efficacy and Safety of NEXIUM for Maintenance of Healing of Erosive Esophagitis in Pediatric Patients 1 to 11 Years of Age
IRB Study ID: 2022-037
The purpose of this study is to look at the use of Nexium in helping to heal Erosive Esophagitis (EE), which is irritation in the pipe that carries food from your mouth to your stomach. This study will look at children aged 1-11 years old.
Study Sponsor:
AstraZeneca
We are currently recruiting
If you are interested in this study or have questions about your child's eligibility, please contact:
Merry Tomcany, mtomcany@akronchildrens.org, 330-543-4616
Who May Qualify:
Patients:
- Age 1-11 years old
- With at least a 3-month history of GERD
- With confirmed presence of EE at time of endoscopy
- Weighing greater than or equal to 10 kg (22 lbs)
Who Does NOT Qualify:
Patients:
- Requiring surgery during the study period
- With a significant clinical illness within 4 weeks prior to the start of treatment
- With a hypersensitivity to Nexium or any other PPI
- Less than 1 or greater than 11 years old
Lead Investigator
Kevin Watson, MD, FAAP
Pediatric Gastroenterologist; Assistant Director, Clinical Informatics, Specialty Systems
Pediatric Gastroenterology
