A Pharmacokinetics, Pharmacodynamics and Safety Study of Rabeprazole in New Born Infants With Gastroesophageal Reflux Disease (GERD)

NCT00855361 | Completed Phase 1

• 2 other identifiers: CR014824RABGRD1005
• Study Type: interventional
• Target: 69
• Locations: 4 countries
• Sites: 19

Brief Summary

The purpose of this study is to evaluate the pharmacokinetics, pharmacodynamics, and the safety of rabeprazole sodium for the treatment of gastroesophageal reflux disease (GERD) in newborns and pre-term infants.

Conditions

Gastroesophageal Reflux

Keywords

Gastroesophageal Reflux; Erosive Gastroesophageal Reflux Disease; Ulcerative Gastroesophageal Reflux Disease; Endoscopy; Pediatrics; GERD; Rabeprazole, Rabeprazole sodium; AcipHex

Outcome Measures

Primary Outcomes (4)

• Rabeprazole plasma concentrations (Parts 1 and 2)

  Up to Day 5

• Thioether metabolite plasma concentrations (Parts 1 and 2)

  Up to Day 5

• The change from baseline in intraesophageal H+ concentration (Parts 1 and 2)

  Baseline, Day 5

• The change from baseline in intragastric H+ concentration (Parts 1 and 2)

  Baseline, Day 5

Secondary Outcomes (1)

• The number of patients with adverse events as a measure of safety and tolerability

  Approximately 8 weeks

Study Arms (1)

Rabeprazole sodium

EXPERIMENTAL

Drug: Rabeprazole sodium

Interventions

Rabeprazole sodium DRUG

One single daily dose of rabeprazole sodium 1 mg as a microgranule formulation for up to 28 consecutive days (Part 1), and one single daily dose of rabeprazole sodium 2 or 3 mg as a microgranule formulation for up to 28 consecutive days (Part 2). The study drug will be administered through a nasogastric or orogastric tube.

Rabeprazole sodium

Eligibility Criteria

• Age: Up to 44 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients must need a feeding tube in place for enteral alimentation (complete or partial) and be in a neonatal intensive care unit or step down unit
• Patients participating in the pHmetry assessment must be in need of this assessment
• New born, neonate or pre-term infants less than 44 weeks with a minimum weight of 0.8 kg and with a presumptive diagnosis of GERD
• Patients who have been treated with, or are currently receiving a proton pump inhibitor (PPI), H2-blockers or antacids
• Patients should be generally healthy, other than for the presence of GERD.

You may not qualify if:

• A history of or current clinically significant medical illness (excluding GERD, asthma, reactive airway disease or cystic fibrosis-dependant GERD)
• Continuous drip tube feeding with formula or breast milk
• Patients whose mothers are taking PPIs and who are pumping breast milk to be fed to their infants
• Continuous positive airway pressure (CPAP) delivered via nasal prong or oral mask
• Serum concentrations of hepatic transaminases \> 3-fold higher than the upper limit of normal for age creatinine values = 106 micromoles/L
• Clinically relevant abnormal laboratory values
• Treatment with full therapeutic doses of sucralfate or any medication that affects gastrointestinal motility such as baclofen, erythromycin, metoclopramide, cisapride, or domperidone
• A history of allergy or sensitivity to PPIs or to their inactive ingredients

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead
• Eisai Inc.: collaborator

Study Sites (19)

Unknown Facility

Orange, California, United States

Location

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Washington D.C., District of Columbia, United States

Location

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Augusta, Georgia, United States

Location

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Maywood, Illinois, United States

Location

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Louisville, Kentucky, United States

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Shreveport, Louisiana, United States

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Lansing, Michigan, United States

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Omaha, Nebraska, United States

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Brooklyn, New York, United States

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Toledo, Ohio, United States

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Aachen, Germany

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Bydgoszcz, Poland

Location

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Lublin Poland, Poland

Location

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Odz, Poland

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Poznan, Poland

Location

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Barnsley, United Kingdom

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Manchester, United Kingdom

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Preston, United Kingdom

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Sheffield, United Kingdom

Location

Related Links

• A Pharmacokinetic, Pharmacodynamic and Short-term Safety Study of Single and Multiple Day Doses of Rabeprazole Sodium in Neonates and Pre-term Infants with a Corrected Age of Less than 44 Weeks with a Presumptive Diagnosis of GERD

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Rabeprazole

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

• Janssen Research & Development, LLC C. Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2009
• First Posted: March 4, 2009
• Study Start: July 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: April 29, 2013

Record last verified: 2013-04

Locations

US (10); DE (1); PL (4); GB (4)