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Optimal Dosing of Omeprazole in Neonates

Information source: Assistance Publique - H˘pitaux de Paris
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Gastroesophageal Reflux Disease (GERD)

Intervention: Omeprazole (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Assistance Publique - H˘pitaux de Paris

Official(s) and/or principal investigator(s):
Evelyne Jacqz-Aigrain, MD, PhD, Principal Investigator, Affiliation: Assistance Publique - H├┤pitaux de Paris


"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."

Clinical Details

Official title: Optimal Dose and Population Pharmacokinetics of Omeprazole in Neonates With Gastroesophageal Reflux Disease (GERD)

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Presence of a normalised control pHmetry Presence of a normalised control pHmetry Presence of a normalised control pHmetry

Secondary outcome:

mean number of reflux episodes per hour

duration of the longest reflux episode

plasma concentrations of omeprazole and its metabolite, hydroxyl-omeprazole

changes in salivary pH monitoring

changes in biological parameters

Detailed description: "Omeprazole is a proton pump inhibitor increasingly prescribed in the neonatal population for gastroesophageal reflux disease (GERD) complicated or not by the presence of esophagitis. Although extensively evaluated in adults, optimal dosing schemas, efficacy and safety have not been determined in the neonatal population where its prescription remains off-label. The study is a double blind trial that was designed using a Bayesian sequential analysis approach. The principle of this approach is to identify the adequate drug dosage to obtain a level of efficacy as close as possible to a predetermined target level of efficacy in the population. In this study, five different dosages of omeprazole are tested (1, 1,5, 2, 2,5, 3 mg/kg/day) and a target probability of successful treatment of 95% has been chosen. To assess the influence of gestational age on omeprazole's efficacy, analysis was stratified on 3 groups: (1) neonates of less than 32 weeks gestational age (GA), (2) neonates born between 32 and 35 weeks of GA, (3) neonates of more than 36 weeks of GA. A total maximum number of 90 neonates is expected to be included (30 neonates per group). Patients' participation in the study ends after completion of the pHmetry of control that is 72 ┬▒24 hours after omeprazole initiation. Patients in the study will all benefit for the management of their GERD from non-pharmacological therapies such as adequate positioning and use of available thickening agents for formula The only pharmacologic agent authorised during study for treating GERD is omeprazole. All other available GERD treatments will not be prescribed."


Minimum age: 35 Weeks. Maximum age: N/A. Gender(s): Both.



- 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 Debr├ę

University Hospital

- Both parents sign written informed consent form

- Affiliated to social security


- 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


- 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

Locations and Contacts

Hospital Robert Debre, Paris 75019, France
Additional Information

Starting date: June 2007
Last updated: October 10, 2012

Page last updated: August 23, 2015

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