Optimal Dose and Population Pharmacokinetics of Omeprazole in Neonates With Gastroesophageal Reflux Disease (GERD) (OMEPRAZOLE-1)

NCT01657578 Phase 2 COMPLETED

"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."

Details

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	Phase 2
Status	COMPLETED
Enrolment	55
Start date	2007-06
Completion	2012-02

Conditions

• Gastroesophageal Reflux Disease (GERD)

Interventions

• Omeprazole

Primary outcomes

• Presence of a normalised control pHmetry Presence of a normalised control pHmetry Presence of a normalised control pHmetry — 72±24 hours after initiation of omeprazole treatment
  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%

Countries

France