Clinical Trial: E3810-A001-313: Efficacy and Safety of 10 mg Rabeprazole for Treating Heartburn in Frequent Sufferers

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

Official Title: E3810-A001-313: Efficacy and Safety of 10 mg Rabeprazole for Treating Heartburn in Frequent Sufferers

Brief Summary: The purpose of this study is to investigate the safety and efficacy of rabeprazole sodium 10 mg in treating frequent heartburn.

Detailed Summary: This is a multicenter, double-blind, randomized, placebo-controlled study to investigate the safety and efficacy of rabeprazole 10 mg in treating frequent heartburn. The study will last for up to five weeks and consists of the following three phases: a one to two week screening period that includes a one-week, single-blind, placebo run-in phase, a two week double-blind, randomized treatment phase, and a one week single-blind, placebo follow-up phase.
Sponsor: Eisai Inc.

Current Primary Outcome: Complete Heartburn Relief During the First Full 24-Hour Period in the ITT Population. [ Time Frame: first 24 hours ]

Subject was considered "complete relief" if he/she did not heartburn during the nighttime of the first dose date and no heartburn during the daytime of 1 day after the first dose date. The difference in complete relief within the first 24 hours between treatment groups was tested using a continuity corrected chi-square test without adjustment baseline heartburn severity.


Original Primary Outcome:

  • All efficacy assessments will be derived from data recorded in the patients’ daily diaries. Patients will record the incidence and severity of their heartburn, symptoms of regurgitation,
  • belching, and bloating, and antacid consumption.


Current Secondary Outcome:

  • Summary of Percentage of Heartburn-free Daytimes, Intent-to-Treat (ITT) Population [ Time Frame: 14-day treatment period. ]
    comparison between placebo and treatment will be analyzed using two-sample t-test.
  • Summary of Percentage of Heartburn-Free Nighttimes,Intent-to-Treat (ITT) Population [ Time Frame: 14-day treatment period. ]
    comparison between placebo and treatment will be analyzed using two-sample t-test.
  • Change From Baseline in Average Regurgitation Severity Score Between Placebo and Rabeprazole. [ Time Frame: 14-day treatment period. ]
    comparison between placebo and treatment will be analyzed using two-sample t-test.
  • Change From Baseline in Average Belching Severity Score Between Placebo and Rabeprazole. [ Time Frame: 14-day treatment period. ]
    comparison between placebo and treatment will be analyzed using two-sample t-test.


Original Secondary Outcome: Adverse event monitoring will assess safety.

Information By: Eisai Inc.

Dates:
Date Received: October 10, 2005
Date Started: October 2005
Date Completion:
Last Updated: March 30, 2010
Last Verified: March 2010