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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

Primary Purpose

GERD

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Rabeprazole sodium

About this trial

This is an interventional treatment trial for GERD focused on measuring Pediatric Pharmacokinetics, Pediatric Pharmacodynamics, Rabeprazole, Pediatric GERD, Aciphex

Eligibility Criteria

1 Year - 11 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Outcomes

Primary Outcome Measures

Pharmacokinetic, pharmacodynamic and safety parameters of rabeprazole will be listed and summarized.

Secondary Outcome Measures

Full Information

NCT ID

NCT00747695

First Posted

September 4, 2008

Last Updated

January 7, 2011

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Collaborators

Eisai Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00747695

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2011

Overall Recruitment Status

Completed

Study Start Date

March 2008 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Collaborators

Eisai Inc.

4. Oversight

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

GERD

Keywords

Pediatric Pharmacokinetics, Pediatric Pharmacodynamics, Rabeprazole, Pediatric GERD, Aciphex

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Rabeprazole sodium

Primary Outcome Measure Information:

Title

Pharmacokinetic, pharmacodynamic and safety parameters of rabeprazole will be listed and summarized.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

11 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Organizational Affiliation

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

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