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

Phase 2

Completed

• Conditions: Gastroesophageal Reflux Disease

• Registration Number: NCT00132496
• Lead Sponsor: Eisai Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-08-19
• Study First Submitted QC: 2005-08-19
• Study First Posted: 2005-08-22
• Primary Completion: 2006-05
• Study Completion: 2006-07
• Results First Submitted: 2009-08-25
• Status Verified: 2009-11
• Results First Submitted QC: 2009-11-02
• Last Update Submitted: 2009-11-02
• Results First Posted: 2009-12-03
• Last Update Posted: 2009-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group	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.

Trial Locations

Locations (25)

Marshall University; 🇺🇸 Huntington, West Virginia, United States

Professional Clinical Research; 🇺🇸 Cadillac, Michigan, United States

University of Pediatrics; 🇺🇸 Mason, Ohio, United States

NE Ohio University College of Medicine; 🇺🇸 Lebanon, Tennessee, United States

Rockwood Clinic North; 🇺🇸 Spokane, Washington, United States

Longmont Medical Research Network; 🇺🇸 Longmont, Colorado, United States

Kentucky Pediatric/Adult Research; 🇺🇸 Bardstown, Kentucky, United States

Community Pediatric Associates; 🇺🇸 Kalamazoo, Michigan, United States

Pediatric Associates of Mount Carmel, Inc.; 🇺🇸 Cincinnati, Ohio, United States

Pediatric Associates of Mt. Carmel; 🇺🇸 Cincinnati, Ohio, United States

Alpine Medical Group; 🇺🇸 Salt Lake City, Utah, United States

Southwest Children's Research Associates; 🇺🇸 San Antonio, Texas, United States

Babies and Beyond Peds; 🇺🇸 New Port Richey, Florida, United States

Dr. Patricia Barrington, Dr. B. Abraham, PC; 🇺🇸 Snellville, Georgia, United States

Multi-specialty Clinical Research; 🇺🇸 Hoffman Estates, Illinois, United States

Winthrop University Hospital; 🇺🇸 Mineola, New York, United States

The Center for Human Nutrition; 🇺🇸 Omaha, Nebraska, United States

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

DeGarmo Institute of Medicine Research; 🇺🇸 Greer, South Carolina, United States

Center for Children's Digestive Health; 🇺🇸 Youngstown, Ohio, United States

Biomedical Research Associates; 🇺🇸 Shippensburg, Pennsylvania, United States

Pharmacotherapy Research Associates; 🇺🇸 Zanesville, Ohio, United States

Focus Research Group; 🇺🇸 Hendersonville, Tennessee, United States

ProMed Healthcare; 🇺🇸 Johnson City, Tennessee, United States

Nova Southeastern University; 🇺🇸 Fort Lauderdale, Florida, United States