A Phase 3 interventional study of rabeprazole sodium and Placebo in Heartburn, sponsored by Eisai Inc.. Completed at 1 site in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2010-04-06.
Sponsored by Eisai Inc. · Phase 3, Interventional, and Treatment
The purpose of this study is to investigate the safety and efficacy of rabeprazole sodium 10 mg in treating frequent heartburn.
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.
99 studies on the registry are indexed under Heartburn; 10 are open to participants now.
This study's enrollment of 629 is above the median of 100 across 80 interventional studies indexed under Heartburn.
Browse Heartburn studies →Eisai Inc. is the lead sponsor of 360 studies on the registry; 7 are open to participants now.
Of its 81 completed or terminated interventional studies of FDA-regulated products, 54 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Oral placebo tablet
Other: Placebo
oral rabeprazole 10 mg enteric-coated tablet
Drug: rabeprazole 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.
Also known as: Aciphex
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.
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
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.
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.
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.
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.
This study was recruited at 39 centers in the US during the period of 10-Oct-2005 and 16-Mar-2006.
| Milestone | Placebo | Rabeprazole 10 mg |
|---|---|---|
| Started | 310 | 319 |
| Completed | 292 | 308 |
| Not completed | 18 | 11 |
| Withdrew: Adverse event | 5 | 2 |
| Withdrew: Lack of efficacy | 0 | 1 |
| Withdrew: Lost to follow-up | 3 | 4 |
| Withdrew: Physician decision | 1 | 1 |
| Withdrew: Withdrawal by subject | 3 | 0 |
| Withdrew: Protocol violation | 3 | 0 |
| Withdrew: Non-compliance with study drug | 2 | 1 |
| Withdrew: Other | 1 | 2 |
comparison between placebo and treatment will be analyzed using two-sample t-test.
Results for this outcome have not been posted.
comparison between placebo and treatment will be analyzed using two-sample t-test.
Results for this outcome have not been posted.
comparison between placebo and treatment will be analyzed using two-sample t-test.
Results for this outcome have not been posted.
comparison between placebo and treatment will be analyzed using two-sample t-test.
Results for this outcome have not been posted.
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.
| participants | Placebo | Rabeprazole 10 mg |
|---|---|---|
| Complete Heartburn Relief During the First Full 24-Hour Period in the ITT Population. | 114 | 163 |
Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 2/310 (0.6%) | 4/310 (1.3%) |
| Rabeprazole 10 mg | — | 1/319 (0.3%) | 7/319 (2.2%) |
| Event | Placebo | Rabeprazole 10 mg |
|---|---|---|
| Appendicitis perforatedGastrointestinal disorders | 1/310 | 0/319 |
| abortion spontaneousPregnancy, puerperium and perinatal conditions | 1/310 | 0/319 |
| Chest painCardiac disorders | 0/310 | 1/319 |
| Event | Placebo | Rabeprazole 10 mg |
|---|---|---|
| NasopharyngitisInfections and infestations | 4/310 | 7/319 |
| Age, Categorical(Participants) | Placebo | Rabeprazole 10 mg | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 285 | 298 | 583 |
| >=65 years | 25 | 21 | 46 |
| Age Continuous(years) | Placebo | Rabeprazole 10 mg | Total |
|---|---|---|---|
| Mean | 45.4 ± 13.3 | 44.1 ± 14.4 | 44.7 ± 13.8 |
| Sex: Female, Male(Participants) | Placebo | Rabeprazole 10 mg | Total |
|---|---|---|---|
| Female | 198 | 186 | 384 |
| Male | 112 | 133 | 245 |
| Race (NIH/OMB)(Participants) | Placebo | Rabeprazole 10 mg | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 2 | 4 |
| Asian | 4 | 5 | 9 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 25 | 31 | 56 |
| White | 236 | 248 | 484 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 43 | 33 | 76 |
| Region of Enrollment(participants) | Placebo | Rabeprazole 10 mg | Total |
|---|---|---|---|
| United States | 310 | 319 | 629 |
This study is completed, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.
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Eisai Inc.