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

NCT00132496 | Completed Phase 2 Results

• 1 other identifier: E3810-A001-202
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 25

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

Outcome Measures

Primary Outcomes (1)

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

  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

Interventions

rabeprazole sodium DRUG

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

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Males and females aged 12 to 16 years with a clinical diagnosis of symptomatic GERD or suspected or endoscopically proven GERD.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (25)

Longmont Medical Research Network

Longmont, Colorado, 80501, United States

Location

Nova Southeastern University

Fort Lauderdale, Florida, 33328, United States

Location

Babies and Beyond Peds

New Port Richey, Florida, 34652, United States

Location

Dr. Patricia Barrington, Dr. B. Abraham, PC

Snellville, Georgia, 30039, United States

Location

Multi-specialty Clinical Research

Hoffman Estates, Illinois, 60194, United States

Location

Kentucky Pediatric/Adult Research

Bardstown, Kentucky, 40004, United States

Location

Professional Clinical Research

Cadillac, Michigan, 49601, United States

Location

Community Pediatric Associates

Kalamazoo, Michigan, 49008, United States

Location

The Center for Human Nutrition

Omaha, Nebraska, 68105, United States

Location

Children's Hospital of Buffalo - Digestive Disease And Nutrition Center

Buffalo, New York, 14222, United States

Location

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

Pediatric Associates of Mount Carmel, Inc.

Cincinnati, Ohio, 45245, United States

Location

Pediatric Associates of Mt. Carmel

Cincinnati, Ohio, 45245, United States

Location

University of Pediatrics

Mason, Ohio, 45040, United States

Location

Center for Children's Digestive Health

Youngstown, Ohio, 44514, United States

Location

Pharmacotherapy Research Associates

Zanesville, Ohio, 43701, United States

Location

Biomedical Research Associates

Shippensburg, Pennsylvania, 17257, United States

Location

DeGarmo Institute of Medicine Research

Greer, South Carolina, 29651, United States

Location

Focus Research Group

Hendersonville, Tennessee, 37075, United States

Location

ProMed Healthcare

Johnson City, Tennessee, 37601, United States

Location

NE Ohio University College of Medicine

Lebanon, Tennessee, 37087, United States

Location

Southwest Children's Research Associates

San Antonio, Texas, 78229, United States

Location

Alpine Medical Group

Salt Lake City, Utah, 84102, United States

Location

Rockwood Clinic North

Spokane, Washington, 99202, United States

Location

Marshall University

Huntington, West Virginia, 25701, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Rabeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Yufang Lu, MD, PhD, Study Director
• Organization: Eisai Medical Research Inc.

201-403-2500

Study Officials

• Yufang Lu

  Eisai Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 19, 2005
• First Posted: August 22, 2005
• Study Start: August 1, 2005
• Primary Completion: May 1, 2006
• Study Completion: July 1, 2006
• Last Updated: December 3, 2009
• Results First Posted: December 3, 2009

Record last verified: 2009-11

Locations

US (25)