Heartburn
Conditions
Keywords
Heartburn, Rabeprazole
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.
Interventions
DRUGrabeprazole 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.
DRUGplacebo
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.
Sponsors
Eisai Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Heartburn Relief During the First Full 24-Hour Period in Intent-to-Treat (ITT) Population | First 24 hours | 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
| Measure | Time frame | Description |
|---|---|---|
| Summary of Percentage of Heartburn-Free Daytimes | 14-day treatment period. | comparison between placebo and treatment will be analyzed using two-sample t-test. |
| Summary of Percentage of Heartburn-Free Nighttimes | 14-day randomized treatment period | — |
| Change From Baseline in Average Regurgitation Severity Score Between Placebo and Rabeprazole | 14 day randomized treatment period | — |
| Change From Baseline in Average Belching Severity Score Between Placebo and Rabeprazole | 14 day randomized treatment period | — |
Countries
United States
Participant flow
Recruitment details
This study was recruited at 38 centers in the US during the period of 13-Oct-2005 and 21-Mar-2006.
Pre-assignment details
The screening phase (1 to 2 weeks) included a 1-week single-blind placebo run-in phase in order to determine baseline heartburn frequency and diary compliance. At the end of the run-in phase, subjects continued the study and entered the randomized treatment phase if they meet the study criteria.
Participants by arm
| Arm | Count |
|---|---|
| Placebo | 312 |
| Rabeprazole 10 mg | 307 |
| Total | 619 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 5 |
| Overall Study | Medication non-compliance | 1 | 2 |
| Overall Study | Other | 0 | 2 |
| Overall Study | Protocol Violation | 0 | 3 |
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | Placebo | Total | Rabeprazole 10 mg |
|---|---|---|---|
| Age Continuous | 48.2 years STANDARD_DEVIATION 14.7 | 48.5 years STANDARD_DEVIATION 14.4 | 48.8 years STANDARD_DEVIATION 14 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 19 Participants | 12 Participants |
| Race (NIH/OMB) Black or African American | 39 Participants | 70 Participants | 31 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 74 Participants | 146 Participants | 72 Participants |
| Race (NIH/OMB) White | 192 Participants | 384 Participants | 192 Participants |
| Region of Enrollment United States | 312 participants | 619 participants | 307 participants |
| Sex: Female, Male Female | 204 Participants | 411 Participants | 207 Participants |
| Sex: Female, Male Male | 108 Participants | 208 Participants | 100 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 312 | 2 / 307 |
| serious Total, serious adverse events | 0 / 312 | 0 / 307 |
Outcome results
Primary
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.
Time frame: First 24 hours
Population: The primary analysis will be on the intent-to-treat (ITT)population. ITT population includes all randomized subjects who received at least one dose of study drug and had at least one post-baseline assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Complete Heartburn Relief During the First Full 24-Hour Period in Intent-to-Treat (ITT) Population | 100 Participants |
| Rabeprazole 10 mg | Complete Heartburn Relief During the First Full 24-Hour Period in Intent-to-Treat (ITT) Population | 121 Participants |
Secondary
Change From Baseline in Average Belching Severity Score Between Placebo and Rabeprazole
Time frame: 14 day randomized treatment period
Secondary
Change From Baseline in Average Regurgitation Severity Score Between Placebo and Rabeprazole
Time frame: 14 day randomized treatment period
Secondary
Summary of Percentage of Heartburn-Free Daytimes
comparison between placebo and treatment will be analyzed using two-sample t-test.
Time frame: 14-day treatment period.
Secondary
Summary of Percentage of Heartburn-Free Nighttimes
Time frame: 14-day randomized treatment period