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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Quality of Life in New Treatable Therapy as Rabeprazole Option for 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

Detailed Summary:
Sponsor: Eisai Co., Ltd.

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Eisai Inc.

Dates:
Date Received: March 18, 2011
Date Started: January 2011
Date Completion:
Last Updated: May 13, 2015
Last Verified: May 2015