A Phase 2 interventional study of Omeprazole in Gastroesophageal Reflux Disease (GERD), sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 35 Weeks and older. Per ClinicalTrials.gov, last updated 2012-10-11.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 2, Interventional, and Treatment
"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."
"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."
1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.
This study's enrollment of 55 is below the median of 72 across 712 interventional studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
EXCLUSION CRITERIA:
omeprazole
Drug: Omeprazole
omeprazole
Drug: Omeprazole
omeprazole
Drug: Omeprazole
administration of Omeprazole
Also known as: administration of Omeprazole
Presence of a normalised control pHmetry Presence of a normalised control pHmetry Presence of a normalised control pHmetry
Normalised control pHmetry is defined by a reflux index (duration that the recorded intra-oesophageal pH is less than 4.0, expressed as a percentage of the total duration of pH monitoring) of less than 5%
Time frame: 72±24 hours after initiation of omeprazole treatment
mean number of reflux episodes per hour
mean number of reflux episodes per hour
Time frame: 72±24 hours after initiation of omeprazole treatment
duration of the longest reflux episode
duration of the longest reflux episode
Time frame: 72±24 hours after initiation of omeprazole treatment
plasma concentrations of omeprazole and its metabolite, hydroxyl-omeprazole
Plasma concentrations of omeprazole and its metabolite, hydroxyl-omeprazole, After the first administration of omeprazole, blood will be collected either between H0.5 and H4 or between H4 and H12 or both
Time frame: H0.5 and H4 or between H4 and H12 after the first administration of omeprazole
changes in salivary pH monitoring
changes in salivary pH monitoring Without treatment period: just before and 3 hours after a meal Under treatment period: just before and just after the insertion of the pHmetry catheter
Time frame: just before and 3 hours after a meal Under treatment period
changes in biological parameters
changes in biological parameters
Time frame: 96±24 hours after initiation of omeprazole treatment
This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris