A Study of Single and Multiple Doses of Rabeprazole in Pediatric Patients With Gastroesophageal Reflux Disease (GERD) 1 to 11 Months Old, Inclusive

This study has been completed.
Sponsor:
Collaborator:
Eisai Inc.
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT00747526
First received: September 4, 2008
Last updated: July 5, 2013
Last verified: July 2013
  Purpose

The purpose of the study is to evaluate the pharmacokinetics (how the drug is absorbed in the body, how it is distributed within the body and removed from the body over time), pharmacodynamics (how the study medication affects the body) and safety of rabeprazole after single and multiple daily administration in infants between the ages of 1 and 11 months, inclusive, with Gastroesophageal Reflux Disease (GERD).


Condition Intervention Phase
Gastroesophageal Reflux Disease (GERD)
Drug: Rabeprazole sodium 5 mg
Drug: Rabeprazole sodium 10 mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pharmacokinetic, Pharmacodynamic and Safety Study of Single and Multiple Doses of Rabeprazole in Pediatric Subjects With GERD 1 to 11 Months Old, Inclusive

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • Pharmacokinetic parameters [ Time Frame: At Days 1, 5, and 10 ] [ Designated as safety issue: No ]
  • Pharmacodynamic parameters [ Time Frame: At Days 1, 5, and 10 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Patients with Adverse Events as a Measure of Safety [ Time Frame: Approximately 9 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 51
Study Start Date: December 2007
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rabeprazole sodium 5 mg Drug: Rabeprazole sodium 5 mg
Type= exact number, unit= mg, number= 5, format= bead suspension formulation, route= oral use. Rabeprazole sodium 0.5 mg/kg (using increments of 1 mg dose) once daily from Day 1 to Day 5; possible extension using 5 mg once daily up to 28 consecutive days.
Experimental: Rabeprazole sodium 10 mg Drug: Rabeprazole sodium 10 mg
Type= exact number, unit= mg, number= 10, format= bead suspension formulation, route= oral use. Rabeprazole sodium 0.5 mg/kg (using increments of 1 mg dose) once daily from Day 1 to up to Day 14; possible extension using 10 mg once daily up to 28 consecutive days.

Detailed Description:

This is an open-label (both physician and patient know the name of the study medication), multicenter, Phase I study, consisting of 2 parts. The first part of the study will be nonrandomized (study drug is intentionally assigned), and all patients will receive the same dose. In the second part of the study, patients will be randomized (study medication assigned by chance) into 2 dose groups. The purpose of the study is to evaluate the pharmacokinetics (PK), pharmacodynamics (intraesophageal/intragastric pH, clinical global impression, formulation palatability and Gastroesophageal Reflux Disease (GERD) daily symptom diary) and safety of rabeprazole after single and multiple daily administration at 2 dose levels in children between the ages of 1 and 11 months, inclusive (up to 11 months 29 days), with GERD. As this study is an exploratory assessment of the PK, pharmacodynamics and safety of rabeprazole in children, no formal hypothesis testing is applied. Safety and tolerability, including monitoring of adverse events, clinical laboratory results, physical examination, vital signs and electrocardiogram measurements (the measuring of the electrical currents in the heart), will be evaluated throughout the study. Patients will receive rabeprazole sodium as single daily oral doses for 5 successive days (Option 1), or up to 14 successive days (10 days minimum) (Option 2) as a bead formulation. In Part 1, patients will receive single and multiple daily (every 24 hours) doses of 0.5 mg/kg, using increments of 1 mg dose. Safety and PK data from Part 1 of the study will determine the 2 dosages to be studied in Part 2 of the study. In Part 2, patients may receive rabeprazole sodium as single daily oral doses for up to a maximum of 28 consecutive days as a bead formulation. Patients will be randomized into either the 5 mg dose or 10 mg dose group.

  Eligibility

Ages Eligible for Study:   1 Month to 11 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Minimum weight of 5 kg (treatment Option 1) or 3 kg (treatment Option 2) with a diagnosis of GERD
  • Informed consent signed by at least one parent
  • Patients who have been treated with, or are currently receiving a proton pump inhibitor (PPI), H2 blockers, or antacids are eligible (as long as they can go off antacids for 24 hours, and PPIs and H2 blockers for three days prior to dosing, except for cimetidine, which must be discontinued for at least seven days prior to dosing) and remain off these medications for the treatment period

Exclusion Criteria:

  • Patients who have history of or current clinically significant medical illness (excluding GERD) including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, infection, or any other illness that the investigator considers should exclude the patient or that could interfere with the interpretation of the study results
  • Primary pulmonary or ears, nose, and throat (ENT) symptoms
  • History of or current presence of peptic ulcers
  • Presence of "warning signals", suggesting cause of vomiting/regurgitation other than GERD
  • Any condition which would make the patient, in the opinion of the Investigator or Sponsor, unsuitable for the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00747526

Locations
United States, Arkansas
Little Rock, Arkansas, United States
United States, California
Oakland, California, United States
United States, District of Columbia
Washington, District of Columbia, United States
United States, Florida
Maitland, Florida, United States
United States, Kentucky
Louisville, Kentucky, United States
United States, Mississippi
Jackson, Mississippi, United States
United States, Missouri
Bridgeton, Missouri, United States
United States, New Jersey
Long Branch, New Jersey, United States
United States, North Carolina
Greenville, North Carolina, United States
United States, Ohio
Cleveland, Ohio, United States
Toledo, Ohio, United States
Youngstown, Ohio, United States
United States, Texas
Houston, Texas, United States
Belgium
Antwerpen, Belgium
Brussel, Belgium
Brazil
Sao Paulo, Brazil
Poland
Lublin, Poland
Warszawa, Poland
United Kingdom
Barnsley N/A, United Kingdom
London, United Kingdom
Sponsors and Collaborators
Janssen Research & Development, LLC
Eisai Inc.
Investigators
Study Director: Janssen Research & Development, LLC Development, L.L.C. Clinical Trial Janssen Research & Development, LLC
  More Information

Additional Information:
No publications provided by Janssen Research & Development, LLC

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT00747526     History of Changes
Other Study ID Numbers: CR013948, RABGRD1003, 2008-000452-27
Study First Received: September 4, 2008
Last Updated: July 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Janssen Research & Development, LLC:
Gastroesophageal Reflux Disease (GERD)
Pediatrics
Pharmacokinetics
Pharmacodynamics
Rabeprazole
GERD
Aciphex

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Rabeprazole
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014