Gastroesophageal Reflux | Rectal and Oral Omeprazole Treatment of Reflux Disease in Infants.
Gastroesophageal Reflux research study
What is the primary objective of this study?
The purpose of this study is to compare the efficacy of oral and rectal omeprazole treatment in infants with gastroesophageal reflux due to esophageal atresia or congenital diaphragmatic hernia.
Who is eligible to participate?
Inclusion Criteria: - age 6-12 weeks - weight: 3 kg or > 3 kg - gastroesophageal reflux as a result of esophageal atresia or congenital diaphragmatic hernia. - Informed consent of both parents Exclusion Criteria: - Allergy to omeprazole - Infants with gastroesophageal reflux as a result of congenital errors of CNS - Changes in the co-medication during the study - Participation in a study that is interfering with this study. - The use of the following co-medication: alprazolam, midazolam, triazolam, carbamazepine, clorazepate, ciclosporin, disulfiram, phenytoin, iron, itraconazole, ketoconazole, voriconazole, methotrexate, ticlopidine, warfarin. - Infants of the non-Caucasian race
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: September 2005
Completed Date: December 2007
Phase: Phase 3
Primary Outcome: Therapeutic efficacy
Secondary Outcome: Intragastric pH, Pharmacokinetic parameters, PK-PD-relation,
Study sponsors, principal investigator, and references
Principal Investigator: D. Tibboel, Prof. Dr.
Lead Sponsor: Rijnstate Hospital
Collaborator: Erasmus Medical Center