Optimal Dosing of Omeprazole in Neonates

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

Summary

"The principal aim of this trial is to determine the minimum effective dose of omeprazole in neonates with GERD objectively diagnosed by a 24-h intra-oesophageal pH monitoring (pHmetry), to obtain a short-term efficacy in the pHmetry of control performed 72 hrs ± 24 after initiation of omeprazole.

The secondary objectives of the study were: (1) to assess the efficacy of omeprazole upon other pHmetry parameters, (2) to characterize the population pharmacokinetics and pharmacogenetics of omeprazole, (3) to evaluate the effect of omeprazole upon oro-pharyngeal pH monitoring and (4) to assess the short-term safety of use of omeprazole in neonates."

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Omeprazole

Criteria

INCLUSION CRITERIA:

• Full-term neonates or preterm neonates with a postmenstrual age >/= 35 weeks

• Presenting abnormal pHmetry (= percentage of the entire record that intra-oesophageal pH is <4 is superior or equal to 5%)

• Patient must receive discontinuous oral feedings

• If proton pump inhibitors or other pharmacologic antireflux therapies had already commenced, these had to be withdrawn 7 days before baseline recordings

• In-patient in Neonatal Intensive Care Unit or Neonatology Unit of the Robert Debré University Hospital

• Both parents sign written informed consent form

• Affiliated to social security

EXCLUSION CRITERIA:

• Patients under proton pump inhibitors (PPI) treatment or that have discontinued PPI treatment less than 7 days before inclusion

• Patients with acute gastrointestinal disease (diarrhoea)

• Patients than present leucopenia or thrombocytopenia (value half the normal value for age)

• Patients that present aspartate and alanine aminotransferase values twice the upper limit of normal

• Patients that present renal and hepatic failure

• Newborns presenting galactosemia, glucose-galactose malabsorption, deficiency in lactase enzymes

• Co-administration of atazanavir and ritonavir

• Patients allergic to omeprazole or to any other ingredients in the medicine