Optimal Dosing of Omeprazole in Neonates

NCT01657578 | Completed Phase 2 DMC

• 2 other identifiers: P 0510432006-005335-16
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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."

Conditions

Gastroesophageal Reflux Disease (GERD)

Keywords

neonates; reflux disease; population pharmacokinetics, omeprazole

Outcome Measures

Primary Outcomes (1)

• 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%

  72±24 hours after initiation of omeprazole treatment

Secondary Outcomes (5)

• mean number of reflux episodes per hour

  72±24 hours after initiation of omeprazole treatment

• duration of the longest reflux episode

  72±24 hours after initiation of omeprazole treatment

• plasma concentrations of omeprazole and its metabolite, hydroxyl-omeprazole

  H0.5 and H4 or between H4 and H12 after the first administration of omeprazole

• changes in salivary pH monitoring

  just before and 3 hours after a meal Under treatment period

• changes in biological parameters

  96±24 hours after initiation of omeprazole treatment

Study Arms (3)

neonates of less than 32 weeks gestational age

EXPERIMENTAL

omeprazole

Drug: Omeprazole

neonates born between 32 and 35 weeks of GA

EXPERIMENTAL

omeprazole

Drug: Omeprazole

neonates of more than 36 weeks of GA

EXPERIMENTAL

omeprazole

Drug: Omeprazole

Interventions

Omeprazole DRUG

administration of Omeprazole

Also known as: administration of Omeprazole

neonates born between 32 and 35 weeks of GA; neonates of less than 32 weeks gestational age; neonates of more than 36 weeks of GA

Eligibility Criteria

• Age: 35 Weeks+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hospital Robert Debre

Paris, 75019, France

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Omeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Evelyne Jacqz-Aigrain, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2012
• First Posted: August 6, 2012
• Study Start: June 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: February 1, 2012
• Last Updated: October 11, 2012

Record last verified: 2012-07

Locations

FR (1)