Clinical Trial: E3810-A001-312: 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-A001-312: 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 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 Intent-to-Treat (ITT) Population [ Time Frame: First 24 hours ]

Original Primary Outcome:

  • The difference in complete relief within the first 24 hours between treatment and placebo will
  • be tested using a continuity corrected chi-square test. The primary analysis will be on ITT
  • population.


Current Secondary Outcome:

  • Summary of Percentage of Heartburn-Free Daytimes [ Time Frame: 14-day treatment period. ]
  • Summary of Percentage of Heartburn-Free Nighttimes [ Time Frame: 14-day randomized treatment period ]
  • Change From Baseline in Average Regurgitation Severity Score Between Placebo and Rabeprazole [ Time Frame: 14 day randomized treatment period ]
  • Change From Baseline in Average Belching Severity Score Between Placebo and Rabeprazole [ Time Frame: 14 day randomized treatment period ]


Original Secondary Outcome:

  • There are four secondary outcomes:
  • (1) reduction of daytime heartburn, (2) reduction of nighttime heartburn, (3) the change from baseline in average regurgitation scores, and
  • (4) the change from baseline in average belching scores, compared with placebo over a 14-day
  • treatment period.
  • Tertiary Outcomes:
  • 1) Reduction in average severity of bloating
  • 2) Reduction of antacid consumption
  • 3) Safety
  • All tested over 14 days using Bonfenoni step-down procedure.


Information By: Eisai Inc.

Dates:
Date Received: October 10, 2005
Date Started: October 2005
Date Completion:
Last Updated: November 4, 2009
Last Verified: November 2009