Heartburn
Conditions
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.
Interventions
DRUGrabeprazole sodium
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.
OTHERPlacebo
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
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.
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 the ITT Population. | first 24 hours | 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
| Measure | Time frame | Description |
|---|---|---|
| Summary of Percentage of Heartburn-free Daytimes, Intent-to-Treat (ITT) Population | 14-day treatment period. | 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 | 14-day treatment period. | 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. | 14-day treatment period. | 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. | 14-day treatment period. | comparison between placebo and treatment will be analyzed using two-sample t-test. |
Countries
United States
Participant flow
Recruitment details
This study was recruited at 39 centers in the US during the period of 10-Oct-2005 and 16-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 oral placebo tablet | 310 |
| Rabeprazole 10 mg oral enteric-coated tablet | 319 |
| Total | 629 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 5 | 2 |
| Overall Study | Lack of Efficacy | 0 | 1 |
| Overall Study | Lost to Follow-up | 3 | 4 |
| Overall Study | non-compliance with study drug | 2 | 1 |
| Overall Study | other | 1 | 2 |
| Overall Study | Physician Decision | 1 | 1 |
| Overall Study | Protocol Violation | 3 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 0 |
Baseline characteristics
| Characteristic | Rabeprazole 10 mg | Total | Placebo |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 21 Participants | 46 Participants | 25 Participants |
| Age, Categorical Between 18 and 65 years | 298 Participants | 583 Participants | 285 Participants |
| Age Continuous | 44.1 years STANDARD_DEVIATION 14.4 | 44.7 years STANDARD_DEVIATION 13.8 | 45.4 years STANDARD_DEVIATION 13.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 9 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 31 Participants | 56 Participants | 25 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 | 33 Participants | 76 Participants | 43 Participants |
| Race (NIH/OMB) White | 248 Participants | 484 Participants | 236 Participants |
| Region of Enrollment United States | 319 participants | 629 participants | 310 participants |
| Sex: Female, Male Female | 186 Participants | 384 Participants | 198 Participants |
| Sex: Female, Male Male | 133 Participants | 245 Participants | 112 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 310 | 7 / 319 |
| serious Total, serious adverse events | 2 / 310 | 1 / 319 |
Outcome results
Primary
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.
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 the ITT Population. | 114 participants |
| Rabeprazole 10 mg | Complete Heartburn Relief During the First Full 24-Hour Period in the ITT Population. | 163 participants |
p-value: <0.001Chi-squared, Corrected
Secondary
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.
Time frame: 14-day treatment period.
Secondary
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.
Time frame: 14-day treatment period.
Secondary
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.
Time frame: 14-day treatment period.
Secondary
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.
Time frame: 14-day treatment period.