Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
A Pharmacokinetic and Safety Study of Single and Multiple Doses of Rabreprazole in Pediatric Patients With Gastroesophageal Reflux Disease (GERD) 1 to 11 Years Old, Inclusive
This study is currently recruiting participants.
Verified by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., December 2008
Sponsors and Collaborators: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Eisai Medical Research Inc.
Information provided by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00747695
  Purpose

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
GERD
Drug: Rabeprazole sodium
Phase I

MedlinePlus related topics: GERD
Drug Information available for: E 3810
U.S. FDA Resources
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

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • Pharmacokinetic, pharmacodynamic and safety parameters of rabeprazole will be listed and summarized.

Estimated Enrollment: 18
Study Start Date: November 2007
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   1 Year to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Boy and girls and a minimum weight of 10 kg with endoscopically proven GERD including an endoscopic examination as part of their diagnostic evaluation
  • 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 3 days prior to dosing, except for cimetidine, which must be discontinued for at least 7 days prior to dosing) and remain off these medications for the treatment period
  • Patients who are generally healthy, other than the presence of GERD, with the exception of the following: Patients with stable asthma/reactive airway disease or cystic fibrosis-dependent GERD symptoms on stable treatment regimens or subjects on stable doses of allergy and attention deficit disorder medicines

Exclusion Criteria:

  • Patients who have a history of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders, lipid abnormalities, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the subject or that could interfere with the interpretation of the study results
  • Primary pulmonary or ENT symptoms
  • Presence of "warning signals", suggesting cause of vomiting/regurgitation other than GERD
  • History of primary esophageal motility disorders or systemic condition affecting the esophagus
  • History of eosinophilic esophagitis, persistent milk protein allergy, or allergic gastroenteropathy
  • History of or current presence of peptic ulcers
  • Current presence of Helicobacter pylori
  • History of definitive acid-lowering surgery
  • Significant arrhythmias
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00747695

Contacts
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

Locations
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
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Eisai Medical Research Inc.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

To learn how to participate in this trial please click here.  This link exits the ClinicalTrials.gov site

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

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Rabeprazole, GERD, Aciphex
Pediatric, Pharmacokinetics
Pharmacodynamics

Study placed in the following topic categories:
Deglutition Disorders
Esophageal Motility Disorders
Digestive System Diseases
Esophageal disorder
Gastrointestinal Diseases
Esophageal Diseases
Gastroesophageal Reflux
Rabeprazole

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009