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

July 5, 2013 updated by: Janssen Research & Development, LLC

A Pharmacokinetic, Pharmacodynamic and Safety Study of Single and Multiple Doses of Rabeprazole in Pediatric Subjects With GERD 1 to 11 Months Old, Inclusive

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerpen, Belgium
      • Brussel, Belgium
  • Brazil
      • Sao Paulo, Brazil
  • Poland
      • Lublin, Poland
      • Warszawa, Poland
  • United Kingdom
      • Barnsley N/A, United Kingdom
      • London, United Kingdom
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • Oakland, California, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Florida
      • Maitland, Florida, United States
    • Kentucky
      • Louisville, Kentucky, United States
    • Mississippi
      • Jackson, Mississippi, United States
    • Missouri
      • Bridgeton, Missouri, United States
    • New Jersey
      • Long Branch, New Jersey, United States
    • North Carolina
      • Greenville, North Carolina, United States
    • Ohio
      • Cleveland, Ohio, United States
      • Toledo, Ohio, United States
      • Youngstown, Ohio, United States
    • Texas
      • Houston, Texas, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 11 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic parameters
Time Frame: At Days 1, 5, and 10
At Days 1, 5, and 10
Pharmacodynamic parameters
Time Frame: At Days 1, 5, and 10
At Days 1, 5, and 10

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Patients with Adverse Events as a Measure of Safety
Time Frame: Approximately 9 weeks
Approximately 9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Research & Development, LLC

Collaborators

Eisai Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

September 4, 2008

First Submitted That Met QC Criteria

September 4, 2008

First Posted (Estimate)

September 5, 2008

Study Record Updates

Last Update Posted (Estimate)

July 8, 2013

Last Update Submitted That Met QC Criteria

July 5, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR013948
  • RABGRD1003 (Other Identifier: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.)
  • 2008-000452-27 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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