E3810-A001-312: Efficacy and Safety of 10 mg Rabeprazole for Treating Heartburn in Frequent Sufferers

This study has been completed.
Sponsor:
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00236197
First received: October 10, 2005
Last updated: November 4, 2009
Last verified: November 2009
  Purpose

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


Condition Intervention Phase
Heartburn
Drug: rabeprazole sodium
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: E3810-A001-312: Efficacy and Safety of 10 mg Rabeprazole for Treating Heartburn in Frequent Sufferers

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Complete Heartburn Relief During the First Full 24-Hour Period in Intent-to-Treat (ITT) Population [ Time Frame: First 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Summary of Percentage of Heartburn-Free Daytimes [ Time Frame: 14-day treatment period. ] [ Designated as safety issue: No ]
  • Summary of Percentage of Heartburn-Free Nighttimes [ Time Frame: 14-day randomized treatment period ] [ Designated as safety issue: No ]
  • Change From Baseline in Average Regurgitation Severity Score Between Placebo and Rabeprazole [ Time Frame: 14 day randomized treatment period ] [ Designated as safety issue: No ]
  • Change From Baseline in Average Belching Severity Score Between Placebo and Rabeprazole [ Time Frame: 14 day randomized treatment period ] [ Designated as safety issue: No ]

Enrollment: 619
Study Start Date: October 2005
Study Completion Date: June 2008
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: rabeprazole sodium
Following a one week single-blind, placebo run-in phase, patients will receive rabeprazole 10 mg orally,placebo once daily, for 14 days during the double-blind, randomized treatment phase. This will be followed by a one week single-blind placebo follow-up phase.
Other Name: Aciphex
Placebo Comparator: 2 Drug: placebo
Following a one week single-blind, placebo run-in phase, patients will receive placebo orally, once daily, for 14 days during the double-blind, randomized treatment phase. This will be followed by a one week single-blind placebo follow-up phase.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Male or female patients > 18 years of age.
  2. If female, not of childbearing potential by reason of surgery or menopause, or of childbearing potential, but using an approved method of contraception since the last menstrual period. Females of childbearing potential must have a negative serum pregnancy test before starting the study.
  3. Patients must report a history of heartburn at least two days per week over the past month.

Key Exclusion Criteria:

  1. History of erosive esophagitis verified by endoscopy.
  2. History of gastroesophageal reflux disease (GERD) diagnosed by a physician.
  3. Patients who have a history of Barrett's esophagus or esophageal stricture.
  4. Evidence of any medical condition that may interfere with the conduct of the study, the interpretation of study results, or the health of the patient during the study.
  5. Patients who require continuous use of proton pump inhibitors, histamine receptor (H2) blockers, or prokinetics. Prior intermittent use of these agents is permitted if they are discontinued at least three days prior to the run-in phase. The H2 blocker, cimetidine (Tagamet®), must be discontinued for at least seven days before the study drug is administered.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00236197

Locations
United States, New York
New York Center For Clinical Research
Lake Success, New York, United States, 11042
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: Yufang Lu Eisai Inc.
  More Information

No publications provided

Responsible Party: Yufang Lu, Study Director, Eisai Medical Research Inc.
ClinicalTrials.gov Identifier: NCT00236197     History of Changes
Other Study ID Numbers: E3810-A001-312
Study First Received: October 10, 2005
Results First Received: August 25, 2009
Last Updated: November 4, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Eisai Inc.:
Heartburn
Rabeprazole

Additional relevant MeSH terms:
Heartburn
Signs and Symptoms, Digestive
Signs and Symptoms
Rabeprazole
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014