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The purpose of this study is to investigate the safety and efficacy of rabeprazole 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rabeprazole sodium | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | First 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Summary of Percentage of Heartburn-Free Daytimes | comparison between placebo and treatment will be analyzed using two-sample t-test. | 14-day treatment period. |
| Summary of Percentage of Heartburn-Free Nighttimes |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yufang Lu | Eisai Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Center For Clinical Research | Lake Success | New York | 11042 | United States |
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.
This study was recruited at 38 centers in the US during the period of 13-Oct-2005 and 21-Mar-2006.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | |
| FG001 | Rabeprazole 10 mg |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | |
| BG001 | Rabeprazole 10 mg | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | Participants | First 24 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yufang Lu, MD, PhD, Study Director | Eisai Medical Research Inc. | 201-403-2500 |
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| ID | Term |
|---|---|
| D006356 | Heartburn |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D064750 | Rabeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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|
|
| placebo | Drug | 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. |
|
| 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 |
| Protocol Violation |
|
| Medication non-compliance |
|
| Other |
|
Total of all reporting groups
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Summary of Percentage of Heartburn-Free Daytimes | comparison between placebo and treatment will be analyzed using two-sample t-test. | Not Posted | Mean | Standard Deviation | Percentage of participants | 14-day treatment period. |
| Secondary | Summary of Percentage of Heartburn-Free Nighttimes | Not Posted | Mean | Standard Deviation | Percentage of participants | 14-day randomized treatment period |
| Secondary | Change From Baseline in Average Regurgitation Severity Score Between Placebo and Rabeprazole | Not Posted | Mean | Standard Deviation | severity score | 14 day randomized treatment period |
| Secondary | Change From Baseline in Average Belching Severity Score Between Placebo and Rabeprazole | Not Posted | Mean | Standard Deviation | severity score | 14 day randomized treatment period |
| 0 |
| 312 |
| 5 |
| 312 |
| EG001 | Rabeprazole 10 mg | 0 | 307 | 2 | 307 |
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| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |