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

NCT ID: NCT00132496

Last Updated: 2009-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2006-07-31

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.

Conditions

Gastroesophageal Reflux Disease

Keywords

GERD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

rabeprazole sodium

administered orally and once daily to patients randomized to receive either 10 mg or 20 mg.

Intervention Type: DRUG

Eligibility 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.

Exclusion Criteria

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.

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Eisai Medical Research Inc.

Principal Investigators

Yufang Lu

Role: STUDY_DIRECTOR

Eisai Inc.

Locations

Longmont Medical Research Network

Longmont, Colorado, United States

Nova Southeastern University

Fort Lauderdale, Florida, 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

Kentucky Pediatric/Adult Research

Bardstown, Kentucky, United States

Professional Clinical Research

Cadillac, Michigan, United States

Community Pediatric Associates

Kalamazoo, Michigan, 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

Winthrop University Hospital

Mineola, New York, United States

Pediatric Associates of Mount Carmel, Inc.

Cincinnati, Ohio, United States

Pediatric Associates of Mt. Carmel

Cincinnati, Ohio, United States

University of Pediatrics

Mason, Ohio, United States

Center for Children's Digestive Health

Youngstown, Ohio, United States

Pharmacotherapy Research Associates

Zanesville, Ohio, United States

Biomedical Research Associates

Shippensburg, Pennsylvania, United States

DeGarmo Institute of Medicine Research

Greer, South Carolina, United States

Focus Research Group

Hendersonville, Tennessee, United States

ProMed Healthcare

Johnson City, Tennessee, United States

NE Ohio University College of Medicine

Lebanon, Tennessee, United States

Southwest Children's Research Associates

San Antonio, Texas, United States

Alpine Medical Group

Salt Lake City, Utah, United States

Rockwood Clinic North

Spokane, Washington, United States

Marshall University

Huntington, West Virginia, United States

Countries

United States

Other Identifiers

E3810-A001-202

Identifier Type: -

Identifier Source: org_study_id