Clinical trial NCT00132496: Treatment of Gastroesophageal Reflux Disease in 12-16 Year Old Patients With Rabeprazole
Official title: Safety and Efficacy of Rabeprazole in the Treatment of Gastroesophageal Reflux Disease in 12-16 Year Old Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastroesophageal Reflux Disease
Keywords: GERD
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2005-08-22
Enrollment: 111
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.
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.

Primary outcomes:
measure: Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group
timeFrame: 8 weeks from randomization and end of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Longmont
country: United States
facility: Longmont Medical Research Network
state: Colorado
city: Fort Lauderdale
country: United States
facility: Nova Southeastern University
state: Florida
city: New Port Richey
country: United States
facility: Babies and Beyond Peds
state: Florida
city: Snellville
country: United States
facility: Dr. Patricia Barrington, Dr. B. Abraham, PC
state: Georgia
city: Hoffman Estates
country: United States
facility: Multi-specialty Clinical Research
state: Illinois
city: Bardstown
country: United States
facility: Kentucky Pediatric/Adult Research
state: Kentucky
city: Cadillac
country: United States
facility: Professional Clinical Research
state: Michigan
city: Kalamazoo
country: United States
facility: Community Pediatric Associates
state: Michigan
city: Omaha
country: United States
facility: The Center for Human Nutrition
state: Nebraska
city: Buffalo
country: United States
facility: Children's Hospital of Buffalo - Digestive Disease And Nutrition Center
state: New York
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: Cincinnati
country: United States
facility: Pediatric Associates of Mount Carmel, Inc.
state: Ohio
city: Cincinnati
country: United States
facility: Pediatric Associates of Mt. Carmel
state: Ohio
city: Mason
country: United States
facility: University of Pediatrics
state: Ohio
city: Youngstown
country: United States
facility: Center for Children's Digestive Health
state: Ohio
city: Zanesville
country: United States
facility: Pharmacotherapy Research Associates
state: Ohio
city: Shippensburg
country: United States
facility: Biomedical Research Associates
state: Pennsylvania
city: Greer
country: United States
facility: DeGarmo Institute of Medicine Research
state: South Carolina
city: Hendersonville
country: United States
facility: Focus Research Group
state: Tennessee
city: Johnson City
country: United States
facility: ProMed Healthcare
state: Tennessee
city: Lebanon
country: United States
facility: NE Ohio University College of Medicine
state: Tennessee
city: San Antonio
country: United States
facility: Southwest Children's Research Associates
state: Texas
city: Salt Lake City
country: United States
facility: Alpine Medical Group
state: Utah
city: Spokane
country: United States
facility: Rockwood Clinic North
state: Washington
city: Huntington
country: United States
facility: Marshall University
state: West Virginia
Study officials:
affiliation: Eisai Inc.
name: Yufang Lu
role: STUDY_DIRECTOR
References: