Refractory Reflux Esophagitis
Conditions
Keywords
rabeprazole sodium, refractory reflux esophagitis
Brief summary
To investigate the efficacy and safety of PARIET twice daily (b.i.d.) in patients with Proton Pump Inhibitor-resistant reflux esophagitis
Interventions
DRUGrabeprazole sodium
Doses of 10 mg or 20 mg twice daily may be administered orally to reflux esophagitis patients for a further 8 weeks when proton pump inhibitor treatment is ineffective. However, a dose of 20 mg twice daily should only be administered to patients with severe mucosa injury.
Sponsors
Eisai Co., Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
; -Proton pump inhibitor-resistant reflux esophagitis. (Patients who have mucosal breaks (erosions, ulcers) on endoscopy)
Exclusion criteria
; * Patients with a history of hypersensitivity to any ingredients of PARIET. * Patients on atazanavir sulfate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of subjects with improvement based on health related Quality of Life (QOL) questionnaire | Check at predose, 4, 8, 16 and 32 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Number of subjects with improvement in symptoms of GERD | Check at predose, 4, 8, 16 and 32 weeks |
| Endoscopic healing rate | 8 weeks |
| Adverse events | Every 4-8 weeks |
Countries
Japan
Outcome results
None listed