Back to resultsE3810-A001-313: Efficacy and Safety of 10 mg Rabeprazole for Treating Heartburn in Frequent Sufferers
Primary Purpose
Heartburn
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
rabeprazole sodium
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Heartburn
Eligibility Criteria
Inclusion Criteria: Male or female patients > 18 years of age. 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. Patients must report a history of heartburn at least two days per week over the past month. Exclusion Criteria: History of erosive esophagitis verified by endoscopy. History of gastroesophageal reflux disease (GERD) diagnosed by a physician. Patients who have a history of Barrett's esophagus or esophageal stricture. 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. 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.
Sites / Locations
- Jeffrey L. Newman
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Rabeprazole sodium 10 mg
Arm Description
Oral placebo tablet
oral rabeprazole 10 mg enteric-coated tablet
Outcomes
Primary Outcome Measures
Complete Heartburn Relief During the First Full 24-Hour Period in the ITT Population.
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.
Secondary Outcome Measures
Summary of Percentage of Heartburn-free Daytimes, Intent-to-Treat (ITT) Population
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
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.
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.
comparison between placebo and treatment will be analyzed using two-sample t-test.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00236184
Brief Title
E3810-A001-313: Efficacy and Safety of 10 mg Rabeprazole for Treating Heartburn in Frequent Sufferers
Official Title
E3810-A001-313: Efficacy and Safety of 10 mg Rabeprazole for Treating Heartburn in Frequent Sufferers
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Eisai Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to investigate the safety and efficacy of rabeprazole sodium 10 mg in treating frequent heartburn.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heartburn
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
629 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral placebo tablet
Arm Title
Rabeprazole sodium 10 mg
Arm Type
Experimental
Arm Description
oral rabeprazole 10 mg enteric-coated tablet
Intervention Type
Drug
Intervention Name(s)
rabeprazole sodium
Other Intervention Name(s)
Aciphex
Intervention Description
Following a one week single-blind, placebo run-in phase, patients will receive rabeprazole 10 mg 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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Complete Heartburn Relief During the First Full 24-Hour Period in the ITT Population.
Description
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.
Time Frame
first 24 hours
Secondary Outcome Measure Information:
Title
Summary of Percentage of Heartburn-free Daytimes, Intent-to-Treat (ITT) Population
Description
comparison between placebo and treatment will be analyzed using two-sample t-test.
Time Frame
14-day treatment period.
Title
Summary of Percentage of Heartburn-Free Nighttimes,Intent-to-Treat (ITT) Population
Description
comparison between placebo and treatment will be analyzed using two-sample t-test.
Time Frame
14-day treatment period.
Title
Change From Baseline in Average Regurgitation Severity Score Between Placebo and Rabeprazole.
Description
comparison between placebo and treatment will be analyzed using two-sample t-test.
Time Frame
14-day treatment period.
Title
Change From Baseline in Average Belching Severity Score Between Placebo and Rabeprazole.
Description
comparison between placebo and treatment will be analyzed using two-sample t-test.
Time Frame
14-day treatment period.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female patients > 18 years of age.
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.
Patients must report a history of heartburn at least two days per week over the past month.
Exclusion Criteria:
History of erosive esophagitis verified by endoscopy.
History of gastroesophageal reflux disease (GERD) diagnosed by a physician.
Patients who have a history of Barrett's esophagus or esophageal stricture.
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yufang Lu, MD, PhD
Organizational Affiliation
Eisai Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Jeffrey L. Newman
City
Vista
State/Province
California
ZIP/Postal Code
92084
Country
United States
12. IPD Sharing Statement
Learn more about this trial
E3810-A001-313: Efficacy and Safety of 10 mg Rabeprazole for Treating Heartburn in Frequent Sufferers
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