Treatment of Gastroesophageal Reflux Disease in 12-16 Year Old Patients With Rabeprazole

November 2, 2009 updated by: Eisai Inc.

Safety and Efficacy of Rabeprazole in the Treatment of Gastroesophageal Reflux Disease in 12-16 Year Old Patients

The primary objective of this study is to collect safety information on rabeprazole 10 mg and 20 mg in the treatment of gastroesophageal reflux disease (GERD) in children aged 12 to 16 years. The secondary objectives are to assess the efficacy of rabeprazole on the improvement of the symptoms of GERD and to explore the relationship of symptom relief to dose received, based on symptom frequency and severity, antacid use, and quality of life (QOL) measures.

Study Overview

Status

Completed

Conditions

Gastroesophageal Reflux Disease

Intervention / Treatment

Drug: rabeprazole sodium

Study Type

Interventional

Enrollment (Actual)

111

Phase

Phase 2

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

United States
- Colorado
  - Longmont, Colorado, United States, 80501
    - Longmont Medical Research Network
- Florida
  - Fort Lauderdale, Florida, United States, 33328
    - Nova Southeastern University
  - New Port Richey, Florida, United States, 34652
    - Babies and Beyond Peds
- Georgia
  - Snellville, Georgia, United States, 30039
    - Dr. Patricia Barrington, Dr. B. Abraham, PC
- Illinois
  - Hoffman Estates, Illinois, United States, 60194
    - Multi-specialty Clinical Research
- Kentucky
  - Bardstown, Kentucky, United States, 40004
    - Kentucky Pediatric/Adult Research
- Michigan
  - Cadillac, Michigan, United States, 49601
    - Professional Clinical Research
  - Kalamazoo, Michigan, United States, 49008
    - Community Pediatric Associates
- Nebraska
  - Omaha, Nebraska, United States, 68105
    - The Center for Human Nutrition
- New York
  - Buffalo, New York, United States, 14222
    - Children's Hospital of Buffalo - Digestive Disease And Nutrition Center
  - Mineola, New York, United States, 11501
    - Winthrop University Hospital
- Ohio
  - Cincinnati, Ohio, United States, 45245
    - Pediatric Associates of Mount Carmel, Inc.
  - Cincinnati, Ohio, United States, 45245
    - Pediatric Associates of Mt. Carmel
  - Mason, Ohio, United States, 45040
    - University of Pediatrics
  - Youngstown, Ohio, United States, 44514
    - Center for Children's Digestive Health
  - Zanesville, Ohio, United States, 43701
    - Pharmacotherapy Research Associates
- Pennsylvania
  - Shippensburg, Pennsylvania, United States, 17257
    - BioMedical Research Associates
- South Carolina
  - Greer, South Carolina, United States, 29651
    - DeGarmo Institute of Medicine Research
- Tennessee
  - Hendersonville, Tennessee, United States, 37075
    - Focus Research Group
  - Johnson City, Tennessee, United States, 37601
    - ProMed HealthCare
  - Lebanon, Tennessee, United States, 37087
    - NE Ohio University College of Medicine
- Texas
  - San Antonio, Texas, United States, 78229
    - Southwest Children's Research Associates
- Utah
  - Salt Lake City, Utah, United States, 84102
    - Alpine Medical Group
- Washington
  - Spokane, Washington, United States, 99202
    - Rockwood Clinic North
- West Virginia
  - Huntington, West Virginia, United States, 25701
    - Marshall University

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

12 years to 16 years (Child)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Males and females aged 12 to 16 years with a clinical diagnosis of symptomatic GERD or suspected or endoscopically proven GERD.
Patients who have ever been treated with, or are currently receiving proton pump inhibitors (PPIs),histamine receptor (H2) blockers, or antacids are eligible (as long as they can go off 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; exclusion criteria 5 and 6). Also, patients should be able to go off PPI therapy for two weeks at the end active drug treatment.
Children with stable asthma/reactive airways disease on stable treatment regimens are eligible.
Children on stable doses of allergy, antiepileptic, antidepressant, and attention deficit disorder medicines are eligible.
Patients must be able and willing to swallow the test drug tablet intact. The ability of the child to swallow an intact tablet must be confirmed by the site at Screening.
The patient is willing and able to give assent to participate.
The patient's parent or guardian gives written informed consent.
Post-pubertal females will be required to be abstinent during the course of the study.
Clinically insignificant laboratory findings.

Exclusion Criteria:

Evidence of significant hepatic, renal, respiratory, endocrine, immune, infectious, hematologic, neurologic, psychiatric, or cardiovascular system abnormalities that would interfere with the conduct of the study, the interpretation of study results, or the health of the patient during the study.
History of primary esophageal motility disorders or systemic condition affecting the esophagus (eg, scleroderma, esophageal infections).
History of eosinophilic esophagitis, persistent milk protein allergy, or allergic gastroenteropathy. History or current presence of peptic ulcers; current presence of Helicobacter pylori.
History of definitive acid-lowering surgery, previous esophageal surgery, or esophageal stricture is disallowed. History of fundoplication or feeding tube insertion is allowed.
Treatment with full therapeutic doses of H2-receptor antagonists or sucralfate within three days prior to dosing (or a shorter washout if agreed to by Investigator and Sponsor), except for cimetidine, which must be discontinued for at least seven days prior to dosing.
Treatment with a proton pump inhibitor within three days prior to dosing (or a shorter washout if agreed to by Investigator and Sponsor).
Inability to have 2-week PPI therapy-free period at end of active drug treatment.
Pregnancy or lactation.
Known or suspected drug addiction or alcohol abuse and/or a positive urine drug screen not explained by medication list; occasional alcohol or tobacco use is not an exclusion criterion.
Unwilling or unable to abide by the requirements of the study or violating the prohibitions and restrictions of the study defined in Section 9.4.
Any condition which would make the patient, in the opinion of the Investigator or Sponsor, unsuitable for the study.
Participation in another investigational drug study within one month prior to dosing.
A history of allergy/sensitivity to proton pump inhibitors or to their inactive ingredients.

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group Time Frame: 8 weeks from randomization and end of treatment	Primary safety outcomes include adverse events, physical examinations and clinical laboratory results. AE results are presented in the table.	8 weeks from randomization and end of treatment

Collaborators and Investigators

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

Sponsor

Eisai Inc.

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

August 1, 2005

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

August 19, 2005

First Submitted That Met QC Criteria