Back to resultsE3810-A001-312: 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 focused on measuring Heartburn, Rabeprazole
Eligibility Criteria
Key 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. Key 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
- New York Center For Clinical Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Complete Heartburn Relief During the First Full 24-Hour Period in Intent-to-Treat (ITT) Population
The difference in complete relief within the first 24 hours between treatment and placebo in ITT was tested using a continuity corrected chi-square test withput adjustment for baseline severity.
Secondary Outcome Measures
Summary of Percentage of Heartburn-Free Daytimes
comparison between placebo and treatment will be analyzed using two-sample t-test.
Summary of Percentage of Heartburn-Free Nighttimes
Change From Baseline in Average Regurgitation Severity Score Between Placebo and Rabeprazole
Change From Baseline in Average Belching Severity Score Between Placebo and Rabeprazole
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00236197
Brief Title
E3810-A001-312: Efficacy and Safety of 10 mg Rabeprazole for Treating Heartburn in Frequent Sufferers
Official Title
E3810-A001-312: Efficacy and Safety of 10 mg Rabeprazole for Treating Heartburn in Frequent Sufferers
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
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
5. Study Description
Brief Summary
The purpose of this study is to investigate the safety and efficacy of rabeprazole 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
Keywords
Heartburn, Rabeprazole
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
619 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
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,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.
Intervention Type
Drug
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 Intent-to-Treat (ITT) Population
Description
The difference in complete relief within the first 24 hours between treatment and placebo in ITT was tested using a continuity corrected chi-square test withput adjustment for baseline severity.
Time Frame
First 24 hours
Secondary Outcome Measure Information:
Title
Summary of Percentage of Heartburn-Free Daytimes
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
Time Frame
14-day randomized treatment period
Title
Change From Baseline in Average Regurgitation Severity Score Between Placebo and Rabeprazole
Time Frame
14 day randomized treatment period
Title
Change From Baseline in Average Belching Severity Score Between Placebo and Rabeprazole
Time Frame
14 day randomized treatment period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key 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.
Key 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
Organizational Affiliation
Eisai Inc.
Official's Role
Study Director
Facility Information:
Facility Name
New York Center For Clinical Research
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
12. IPD Sharing Statement
Learn more about this trial
E3810-A001-312: Efficacy and Safety of 10 mg Rabeprazole for Treating Heartburn in Frequent Sufferers
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