Gastroesophageal Reflux Disease
Conditions
Keywords
GERD
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.
Interventions
DRUGrabeprazole sodium
administered orally and once daily to patients randomized to receive either 10 mg or 20 mg.
Sponsors
Eisai Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 16 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
This study was recruited at 25 centers in the US during the period of 18-Aug-2005 and 1-May-2006.
Pre-assignment details
There was a screening period of up to 2 days before treatment assignment
Participants by arm
| Arm | Count |
|---|---|
| Rabeprazole 10 mg once daily for 8 weeks | 54 |
| Rabeprazole 20 mg once daily for 8 weeks | 57 |
| Total | 111 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Rabeprazole 20 mg | Total | Rabeprazole 10 mg |
|---|---|---|---|
| Age Continuous | 14.1 years STANDARD_DEVIATION 1.5 | 14.2 years STANDARD_DEVIATION 1.4 | 14.2 years STANDARD_DEVIATION 1.3 |
| Race/Ethnicity, Customized Asian | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Black or African American | 1 participants | 5 participants | 4 participants |
| Race/Ethnicity, Customized Hispanic | 2 participants | 3 participants | 1 participants |
| Race/Ethnicity, Customized Other | 1 participants | 3 participants | 2 participants |
| Race/Ethnicity, Customized White | 53 participants | 100 participants | 47 participants |
| Region of Enrollment United States | 57 participants | 111 participants | 54 participants |
| Sex: Female, Male Female | 26 Participants | 53 Participants | 27 Participants |
| Sex: Female, Male Male | 31 Participants | 58 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 41 / — | 45 / — |
| serious Total, serious adverse events | 0 / — | 1 / — |
Outcome results
Primary
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.
Time frame: 8 weeks from randomization and end of treatment
Population: Safety population (all patients who received at least one dose of study treatment) was the primary analysis population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rabeprazole 10 mg | Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group | Upper respiratory tract infection | 4 Participants |
| Rabeprazole 10 mg | Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group | Nasopharyngitis | 1 Participants |
| Rabeprazole 10 mg | Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group | Nausea | 3 Participants |
| Rabeprazole 10 mg | Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group | Otitis media | 1 Participants |
| Rabeprazole 10 mg | Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group | Bronchitis | 3 Participants |
| Rabeprazole 10 mg | Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group | Headache | 5 Participants |
| Rabeprazole 10 mg | Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group | Chest pain | 0 Participants |
| Rabeprazole 10 mg | Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group | Pharyngolaryngeal pain | 6 Participants |
| Rabeprazole 10 mg | Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group | Pharyngitis | 3 Participants |
| Rabeprazole 10 mg | Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group | Cough | 5 Participants |
| Rabeprazole 10 mg | Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group | Upper abdominal pain | 1 Participants |
| Rabeprazole 10 mg | Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group | Nasal congestion | 4 Participants |
| Rabeprazole 10 mg | Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group | Sinusitis | 2 Participants |
| Rabeprazole 10 mg | Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group | Total # subjects reporting AEs | 41 Participants |
| Rabeprazole 10 mg | Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group | Diarrhea | 3 Participants |
| Rabeprazole 20 mg | Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group | Total # subjects reporting AEs | 45 Participants |
| Rabeprazole 20 mg | Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group | Diarrhea | 2 Participants |
| Rabeprazole 20 mg | Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group | Nausea | 2 Participants |
| Rabeprazole 20 mg | Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group | Upper abdominal pain | 3 Participants |
| Rabeprazole 20 mg | Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group | Chest pain | 3 Participants |
| Rabeprazole 20 mg | Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group | Upper respiratory tract infection | 3 Participants |
| Rabeprazole 20 mg | Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group | Bronchitis | 2 Participants |
| Rabeprazole 20 mg | Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group | Pharyngitis | 2 Participants |
| Rabeprazole 20 mg | Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group | Sinusitis | 3 Participants |
| Rabeprazole 20 mg | Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group | Nasopharyngitis | 4 Participants |
| Rabeprazole 20 mg | Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group | Otitis media | 3 Participants |
| Rabeprazole 20 mg | Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group | Headache | 6 Participants |
| Rabeprazole 20 mg | Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group | Pharyngolaryngeal pain | 5 Participants |
| Rabeprazole 20 mg | Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group | Cough | 3 Participants |
| Rabeprazole 20 mg | Treatment-emergent Adverse Events Experienced by >=5% of Patients in Any Treatment Group | Nasal congestion | 4 Participants |