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

Gastroesophageal Reflux Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00132496
• Other study ID #: E3810-A001-202
• Status: Completed
• Phase: Phase 2
• First received: August 19, 2005
• Last updated: November 2, 2009
• Start date: August 2005
• Est. completion date: July 2006

Study information

• Verified date: November 2009
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: July 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 16 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Drug:
• rabeprazole sodium
administered orally and once daily to patients randomized to receive either 10 mg or 20 mg.

Locations

Country	Name	City	State
United States	Kentucky Pediatric/Adult Research	Bardstown	Kentucky
United States	Children's Hospital of Buffalo - Digestive Disease And Nutrition Center	Buffalo	New York
United States	Professional Clinical Research	Cadillac	Michigan
United States	Pediatric Associates of Mount Carmel, Inc.	Cincinnati	Ohio
United States	Pediatric Associates of Mt. Carmel	Cincinnati	Ohio
United States	Nova Southeastern University	Fort Lauderdale	Florida
United States	DeGarmo Institute of Medicine Research	Greer	South Carolina
United States	Focus Research Group	Hendersonville	Tennessee
United States	Multi-specialty Clinical Research	Hoffman Estates	Illinois
United States	Marshall University	Huntington	West Virginia
United States	ProMed Healthcare	Johnson City	Tennessee
United States	Community Pediatric Associates	Kalamazoo	Michigan
United States	NE Ohio University College of Medicine	Lebanon	Tennessee
United States	Longmont Medical Research Network	Longmont	Colorado
United States	University of Pediatrics	Mason	Ohio
United States	Winthrop University Hospital	Mineola	New York
United States	Babies and Beyond Peds	New Port Richey	Florida
United States	The Center for Human Nutrition	Omaha	Nebraska
United States	Alpine Medical Group	Salt Lake City	Utah
United States	Southwest Children's Research Associates	San Antonio	Texas
United States	Biomedical Research Associates	Shippensburg	Pennsylvania
United States	Dr. Patricia Barrington, Dr. B. Abraham, PC	Snellville	Georgia
United States	Rockwood Clinic North	Spokane	Washington
United States	Center for Children's Digestive Health	Youngstown	Ohio
United States	Pharmacotherapy Research Associates	Zanesville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group		8 weeks from randomization and end of treatment	Yes