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| Sponsor: | Janssen Research & Development, LLC |
|---|---|
| Collaborator: |
Eisai Inc. |
| Information provided by: | Janssen Research & Development, LLC |
| ClinicalTrials.gov Identifier: | NCT00747526 |
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 |
| 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.
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Arkansas | |
| Little Rock, Arkansas, United States | |
| United States, California | |
| Oakland, California, United States | |
| United States, District of Columbia | |
| Was, 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, 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 | |
| Study Director: | Janssen Research & Development, LLC Development, L.L.C. Clinical Trial | Janssen Research & Development, LLC |
More Information
| Responsible Party: | Clinical Leader, 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: | May 1, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Gastroesophageal Reflux Disease (GERD) Pediatrics Pharmacokinetics Pharmacodynamics |
Rabeprazole GERD Aciphex |
|
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 |