* Tolerability and Safety of Oral Pantoprazole in Pediatric Participants
Research type
Research Study
Full title
AN EXPLORATORY, MULTICENTER, RANDOMIZED, DOUBLE BLIND STUDY OF CLINICAL OUTCOMES, TOLERABILITY, AND SAFETY OF 2 DOSES OF ORAL PANTOPRAZOLE IN PEDIATRIC PARTICIPANTS AGED 1 TO 11 YEARS AND 12 TO 17 YEARS WHO REQUIRE MAINTENANCE THERAPY FOR HEALED EROSIVE ESOPHAGITIS
IRAS ID
292809
Contact name
Katherine Murtagh
Contact email
Sponsor organisation
Pfizer Inc.
Eudract number
2020-005030-15
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 5 months, 26 days
Research summary
The purpose of this study is to learn about the effects of a medicine called Protonix (pantoprazole) and to find the best dose to treat a medical condition called erosive oesophagitis in children aged 1 to 17 years. Erosive oesophagitis is a medical condition which can cause swelling, irritation, inflammation, pain, and sores in the oesophagus, the tube that runs from the throat into the stomach. The study will last for about 36 weeks and will include around 126 children from approximately 15 countries across the world.
Before the study starts, the participant will undergo procedures to make sure that they meet all the requirements for the study. These procedures will also be conducted at different times during the study to see how they are doing during throughout the study.
This study will require will up to 6 study visits to the clinic and 5 telephone follow-up visits with the study nurse or doctor.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
22/EE/0196
Date of REC Opinion
21 May 2021
REC opinion
Further Information Favourable Opinion