Clinical Trial: A Double-blind Comparative Study of the Efficacy and Safety of E3810 10mg Once and Twice Daily in Maintenance Therapy for PPI Resistant Gastroesophageal Reflux Disease Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Double-blind Comparative Study of the Efficacy and Safety of E3810 10mg Once and Twice Daily in Maintenance Therapy for PPI Resistant Gastroesophageal Reflux Disease Pat

Brief Summary: The purpose of this study is to assess the efficacy and safety of E3810 10mg once and twice daily in maintenance therapy for PPI resistant gastroesophageal reflux disease patients.

Detailed Summary: This is randomized, multicenter, parallel-group, double-blind trial that investigates the efficacy and safety of E3810 10mg twice daily over a period of 52 weeks. The non-recurrence rate as endoscopically confirmed at 52 weeks shall be the primary end point, and this shall be examined through a randomized, multicenter, parallel-group, double-blind trial that investigates the efficacy and safety of E3810 10mg twice daily over a period of 52 weeks.
Sponsor: Eisai Co., Ltd.

Current Primary Outcome: Rate of non-recurrence according to endoscopic findings (modified Los Angeles Classification) after the 52nd week of the maintenance therapy period [ Time Frame: At Week 52 ]

The non-recurrence rate as endoscopically confirmed at 52 weeks shall be examined through the maintenance period that investigates the efficacy and safety of E3810 10 mg twice daily over a period of 52 weeks.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Rate of non-recurrence according to endoscopic findings (modified Los Angeles Classification) after the12th and 24th week of the maintenance therapy period [ Time Frame: At Weeks 12 and 24 ]
  • Period between randomization and recurrence of disease [ Time Frame: Up to 52 Weeks ]
  • Incidence of heartburn (daytime / nighttime) during the maintenance therapy period [ Time Frame: Up to 52 Weeks ]
    A comparison of the E3810 10 mg once daily group and the E3810 10 mg twice daily group shall be performed for subjects who did not exhibit daytime or nighttime heartburn at 0 week of the maintenance therapy period, using a X2 test for the incidence of heartburn in each evaluation period of the maintenance therapy period. Daytime and nighttime heartburn, and nighttime sleep disorders shall likewise be compared.
  • Frequency of heartburn (daytime / nighttime) during the maintenance therapy period [ Time Frame: Up to 52 Weeks ]
    A comparison of the E3810 10 mg once daily group and the E3810 10 mg twice daily group shall be performed for subjects who did not exhibit daytime or nighttime heartburn at 0 week of the maintenance therapy period, using a X2 test for the incidence of heartburn in each evaluation period of the maintenance therapy period. Daytime and nighttime heartburn, and nighttime sleep disorders shall likewise be compared.
  • Severity of heartburn (daytime / nighttime) during the maintenance therapy period [ Time Frame: Up to 52 Weeks ]
    A comparison of the E3810 10 mg once daily group and the E3810 10 mg twice daily group shall be performed for subjects who did not exhibit daytime or nighttime heartburn at 0 week of the maintenance therapy period, using a X2 test for the incidence of heartburn in each evaluation period of the maintenance therapy period. Daytime and nighttime heartburn, and nighttime sleep disorders shall likewise be compared.
  • Incidence of sleep disorders during the maintenance therapy period [ Time Frame: Up to 52 Weeks ]
    In order to evaluate sleep disorders arising from heartburn or acid reflux, if sleep-inducing drugs are being taken before enrollment, as far as possible the type, method of use and dose of the sleep-inducing drug used should not be changed after enrollment.
  • Frequency of sleep disorders during the maintenance therapy period [ Time Frame: Up to 52 Weeks ]
    In order to evaluate sleep disorders arising from heartburn or acid reflux, if sleep-inducing drugs are being taken before enrollment, as far as possible the type, method of use and dose of the sleep-inducing drug used should not be changed after enrollment.


Original Secondary Outcome: Same as current

Information By: Eisai Inc.

Dates:
Date Received: March 24, 2014
Date Started: September 2013
Date Completion:
Last Updated: September 28, 2016
Last Verified: September 2016