Treatment of Gastroesophageal Reflux Disease in 12-16 Year Old Patients With Rabeprazole
Information source: Eisai Medical Research Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gastroesophageal Reflux Disease
Intervention: Rabeprazole Sodium (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Eisai Medical Research Inc. Official(s) and/or principal investigator(s):
Claudio Pasquinelli, Study Director, Affiliation: Eisai Medical Research Inc.
Summary
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.
Clinical Details
Study design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study
Eligibility
Minimum age: 12 Years.
Maximum age: 16 Years.
Gender(s): Both.
Criteria:
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 antagonists (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). Patients should be able to go off PPI
therapy for two weeks at the end of 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 are disallowed. History of fundoplication or feeding tube
insertion are 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.
- 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.
Locations and Contacts
Longmont Medical Research Network, Longmont, Colorado 80501, United States
Babies and Beyond Peds, New Port Richey, Florida 34652, United States
Nova Southeastern University College of Osteopathic Medicine, Fort Lauderdale, Florida 33328, United States
Dr. Patricia Barrington, Dr. B. Abraham, PC, Snellville, Georgia 30039, United States
Center For Children's Digestive Health, Hoffman Estates, Illinois 60194, United States
Kentucky Pediatric/Adult Research, Bardstown, Kentucky 40004, United States
Professional Clinical Research, Cadillac, Michigan 49601, United States
ProMed Healthcare, Kalamazoo, Michigan 49008, United States
The Center for Human Nutrition, Omaha, Nebraska 68105, United States
Children's Hospital of Buffalo - Digestive Disease & Nutrition Center, Buffalo, New York 14222, United States
Winthrop University Hospital, Mineola,, New York 11501, United States
Pediatric Associates of Mt. Carmel, Cincinnati, Ohio 45245, United States
Pharmacotherapy Research Associates, Zanesville, Ohio 43701, United States
Community Pediatric Associates, Mason, Ohio 45040, United States
NE Ohio University College of Medicine, Youngstown, Ohio 44514, United States
Pediatric Associates of Mount Carmel, Inc., Cincinnati, Ohio 45245, United States
Biomedical Research Associates, Shippensburg, Pennsylvania 17257, United States
DeGarmo Intitute of Medical Research, Greer, South Carolina 29651, United States
Multi-specialty Clinical Research, Johnson City, Tennessee 37601, United States
Focus Research Group, Hendersonville, Tennessee 37075, United States
Southwest Children's Research Associates, San Antonio, Texas 78229, United States
Alpine Medical Group, Salt Lake City, Utah 84102, United States
Advanced Pediatrics, Vienna, Virginia 22180, United States
Rockwood Clinic North, Spokane, Washington 99202, United States
Marshall University - University of Pediatrics, Huntington, West Virginia 25701-3655, United States
Additional Information
Starting date: August 2005
Last updated: May 18, 2006
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