Quality of Life in New Treatable Therapy as Rabeprazole Option for Refractory Reflux Esophagitis

Eisai Co., Ltd.2,157 enrolled

Overview

To investigate the efficacy and safety of PARIET twice daily (b.i.d.) in patients with Proton Pump Inhibitor-resistant reflux esophagitis

Study Type

OBSERVATIONAL

Enrollment

2,157

Conditions

Refractory Reflux Esophagitis

Interventions

rabeprazole sodiumDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (447)

Outcomes

Primary Outcomes

Number of subjects with improvement based on health related Quality of Life (QOL) questionnaire

Time frame: Check at predose, 4, 8, 16 and 32 weeks

Secondary Outcomes

Number of subjects with improvement in symptoms of GERD

Time frame: Check at predose, 4, 8, 16 and 32 weeks

Endoscopic healing rate

Time frame: 8 weeks

Adverse events

Time frame: Every 4-8 weeks

Data from ClinicalTrials.gov

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Unnamed facility

Aisai, Aichi-ken, Japan

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Anjo, Aichi-ken, Japan

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Gamagōri, Aichi-ken, Japan

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Ichinomiya, Aichi-ken, Japan

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Inuyama, Aichi-ken, Japan

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Kariya, Aichi-ken, Japan

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Kasugai, Aichi-ken, Japan

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Nagoya, Aichi-ken, Japan

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Okazaki, Aichi-ken, Japan

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Owariasahi, Aichi-ken, Japan

...and 437 more locations