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

Completed

• Conditions: Refractory Reflux Esophagitis
• Interventions: Drug: rabeprazole sodium

• Registration Number: NCT01321567
• Lead Sponsor: Eisai Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-01
• Study First Submitted: 2011-03-18
• Study First Submitted QC: 2011-03-22
• Study First Posted: 2011-03-23
• Primary Completion: 2013-03-01
• Study Completion: 2013-08-01
• Status Verified: 2015-05
• Last Update Submitted: 2023-07-21
• Last Update Posted: 2023-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2157

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rabeprazole Sodium	rabeprazole sodium	-

Primary Outcome Measures

Name	Time	Method
Number of subjects with improvement based on health related Quality of Life (QOL) questionnaire	Check at predose, 4, 8, 16 and 32 weeks

Secondary Outcome Measures

Name	Time	Method
Adverse events	Every 4-8 weeks
Endoscopic healing rate	8 weeks
Number of subjects with improvement in symptoms of GERD	Check at predose, 4, 8, 16 and 32 weeks