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Sponsors and Collaborators: |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Eisai Medical Research Inc. |
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Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00747695 |
The purpose of the study is to evaluate the pharmacokinetics, pharmacodynamics and safety of rabeprazole after single and multiple daily administration in children between the ages of 1 and 11 years, inclusive, with GERD.
Condition | Intervention | Phase |
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GERD |
Drug: Rabeprazole sodium |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Single Group Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | A Pharmacokinetic and Safety Study of Single and Multiple Doses of Rabreprazole in Pediatric Patients With GERD 1 to 11 Years Old, Inclusive |
Estimated Enrollment: | 18 |
Study Start Date: | November 2007 |
This is an open-label (both the physician and the patient know the name of the study medication), multi-center, Phase 1 study, consisting of 2 parts. The first part of the study will be non-randomized, 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, pharmacodynamics (clinical global impressions and formulation palatability) and safety of rabrepazole after single and multiple daily administration at 2 dose levels in children between the ages of 1 and 11 years, inclusive, with GERD. As this study is an exploratory assessment of the pharmacokinetics, 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 ECG measurements, will be evaluated throughout the study.
Patients will receive rabeprazole sodium as single daily oral doses for 5 successive days as a bead formulation. Patients in the first part of the study will receive single and multiple daily every 24 hours doses of 0.14 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.
Ages Eligible for Study: | 1 Year to 11 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: | info1@veritasmedicine.com |
United States, District of Columbia | |
Recruiting | |
Was, District of Columbia, United States, 20010 | |
United States, Kentucky | |
Recruiting | |
Louiseville, Kentucky, United States, 40202 | |
United States, Louisiana | |
Active, not recruiting | |
Marrero, Louisiana, United States, 70072 | |
United States, Michigan | |
Recruiting | |
Southfield, Michigan, United States, 48075 | |
United States, Mississippi | |
Recruiting | |
Jackson, Mississippi, United States, 39216 | |
United States, New Jersey | |
Recruiting | |
Long Branch, New Jersey, United States, 07740 | |
United States, Ohio | |
Recruiting | |
Cleveland, Ohio, United States, 44106 | |
Recruiting | |
Youngstown, Ohio, United States, 44514 | |
United States, Utah | |
Recruiting | |
Salt Lake City, Utah, United States, 84113 | |
United States, West Virginia | |
Recruiting | |
Huntington, West Virginia, United States, 25701 | |
Belgium | |
ZNA Koningin Paola Kinderziekenhuis | Recruiting |
Antwerpen, Belgium, 2020 | |
Contact: Gigi Veereman +3232802130 | |
Principal Investigator: GIGI VEEREMAN | |
Sint-Vincentiusziekenhuis | Recruiting |
Antwerpen, Belgium, 2018 | |
Contact: Andre Vertruyen +3232852835 | |
Principal Investigator: ANDRE VERTRUYEN | |
Cliniques Universitaires St-Luc | Recruiting |
Brussel, Belgium, 1200 | |
Contact: Etienne Sokal +3227641387 | |
Principal Investigator: ETIENNE SOKAL | |
UZ Brussel | Recruiting |
Brussel, Belgium, 1090 | |
Contact: Yvan Vandenplas +3224775781 | |
Principal Investigator: YVAN VANDENPLAS | |
Brazil | |
Not yet recruiting | |
Porto Alegre, Brazil, 90035-903 | |
Not yet recruiting | |
Sao Paulo, Brazil, 02276-140 |
Study Director: | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Study ID Numbers: | CR013945 |
Study First Received: | September 4, 2008 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00747695 |
Health Authority: | United States: Food and Drug Administration |
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