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

Information source: Eisai Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Gastroesophageal Reflux Disease

Intervention: rabeprazole sodium (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Eisai Inc.

Official(s) and/or principal investigator(s):
Yufang Lu, Study Director, Affiliation: Eisai 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

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group

Eligibility

Minimum age: 12 Years. Maximum age: 16 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Males and females aged 12 to 16 years with a clinical diagnosis of symptomatic GERD or suspected or endoscopically proven GERD. 2. 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. 3. Children with stable asthma/reactive airways disease on stable treatment regimens are eligible. 4. Children on stable doses of allergy, antiepileptic, antidepressant, and attention deficit disorder medicines are eligible. 5. 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. 6. The patient is willing and able to give assent to participate. 7. The patient's parent or guardian gives written informed consent. 8. Post-pubertal females will be required to be abstinent during the course of the study. 9. Clinically insignificant laboratory findings. Exclusion Criteria: 1. 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. 2. History of primary esophageal motility disorders or systemic condition affecting the esophagus (eg, scleroderma, esophageal infections). 3. History of eosinophilic esophagitis, persistent milk protein allergy, or allergic gastroenteropathy. History or current presence of peptic ulcers; current presence of Helicobacter pylori. 4. History of definitive acid-lowering surgery, previous esophageal surgery, or esophageal stricture is disallowed. History of fundoplication or feeding tube insertion is allowed. 5. 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. 6. Treatment with a proton pump inhibitor within three days prior to dosing (or a shorter washout if agreed to by Investigator and Sponsor). 7. Inability to have 2-week PPI therapy-free period at end of active drug treatment. 8. Pregnancy or lactation. 9. 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. 10. 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. 11. Any condition which would make the patient, in the opinion of the Investigator or Sponsor, unsuitable for the study. 12. Participation in another investigational drug study within one month prior to dosing. 13. 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

Nova Southeastern University, Fort Lauderdale, Florida 33328, United States

Babies and Beyond Peds, New Port Richey, Florida 34652, United States

Dr. Patricia Barrington, Dr. B. Abraham, PC, Snellville, Georgia 30039, United States

Multi-specialty Clinical Research, Hoffman Estates, Illinois 60194, United States

Kentucky Pediatric/Adult Research, Bardstown, Kentucky 40004, United States

Professional Clinical Research, Cadillac, Michigan 49601, United States

Community Pediatric Associates, Kalamazoo, Michigan 49008, United States

The Center for Human Nutrition, Omaha, Nebraska 68105, United States

Children's Hospital of Buffalo - Digestive Disease And Nutrition Center, Buffalo, New York 14222, United States

Winthrop University Hospital, Mineola, New York 11501, United States

Pediatric Associates of Mount Carmel, Inc., Cincinnati, Ohio 45245, United States

Pediatric Associates of Mt. Carmel, Cincinnati, Ohio 45245, United States

University of Pediatrics, Mason, Ohio 45040, United States

Center for Children's Digestive Health, Youngstown, Ohio 44514, United States

Pharmacotherapy Research Associates, Zanesville, Ohio 43701, United States

Biomedical Research Associates, Shippensburg, Pennsylvania 17257, United States

DeGarmo Institute of Medicine Research, Greer, South Carolina 29651, United States

Focus Research Group, Hendersonville, Tennessee 37075, United States

ProMed Healthcare, Johnson City, Tennessee 37601, United States

NE Ohio University College of Medicine, Lebanon, Tennessee 37087, United States

Southwest Children's Research Associates, San Antonio, Texas 78229, United States

Alpine Medical Group, Salt Lake City, Utah 84102, United States

Rockwood Clinic North, Spokane, Washington 99202, United States

Marshall University, Huntington, West Virginia 25701, United States

Additional Information

Starting date: August 2005
Last updated: November 2, 2009

Page last updated: August 20, 2015

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