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The purpose of this study to determine the efficacy of 20 mg of rabeprazole given as a maintenance intermittent therapy following acute treatment for Symptomatic Gastroesophageal Reflux Disease (s-GERD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Rabeprazole 20 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rabeprazole 20 mg | Drug | rabeprazole sodium tablet 20 mg once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Heartburn-free Days (24-hour Periods) During the 6-month Maintenance Treatment Phase (ITT Population). | The percentage of heartburn-free days during the 6-month Maintenance Treatment Phase in patients treated with rabeprazole 20 mg compared to patients who received placebo in the ITT Population. Heartburn-free day was defined as no heartburn in both the daytime and nighttime period on a given day. Note a total 388 subjects were enrolled at the beginning of Acute Phase and 200 subjects were enrolled into the double-blind 6-month maintenance treatment phase. | 6 months double-blind maintenance phase |
| Measure | Description | Time Frame |
|---|---|---|
| The Percent of Heartburn-free Daytime Period During the 6-month Maintenance Treatment Phase | The percentage of heartburn-free daytime period is presented cumulatively including all data collected during the 6-month Maintenance Phase | 6-month maintenance phase |
| The Percent of Heartburn-free Nighttime Period During the 6-month Maintenance Treatment Phase |
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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 |
|---|---|---|---|---|---|---|
| Quality Care Medical Center Inc. | Vista | California | 92085 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20132154 | Derived | Fass R, Delemos B, Nazareno L, Kao R, Xiang J, Lu Y. Clinical trial: maintenance intermittent therapy with rabeprazole 20 mg in patients with symptomatic gastro-oesophageal reflux disease - a double-blind, placebo-controlled, randomized study. Aliment Pharmacol Ther. 2010 May;31(9):950-60. doi: 10.1111/j.1365-2036.2010.04254.x. Epub 2010 Feb 2. |
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After enrollment and before randomization (treatment assignment), there was a 2-week placebo run-in phase followed by a 4-week open-label Acute Phase during which subjects were treated with rabeprazole 20 mg once daily for the treatment of heartburn. Note the below participant flow is based on Safety Population (total 200 subjects).
This study was recruited at 47 centers in the US during the period of 7-Oct-2004 and 12-Dec-2005.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rabeprazole 20 mg | Orally, once daily for 7- to 14-day courses intermittently during the 6-month Double-blind Maintenance Treatment Phase. |
| FG001 | Placebo | Orally, once daily for 7- to 14-day courses intermittently during the 6-month Double-blind Maintenance Treatment Phase. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rabeprazole 20 mg | Orally, once daily for 7 to 14-day courses intermittently during the 6-month Maintenance Treatment Phase (ITT population). |
| BG001 | Placebo | Orally, once daily for 7 to 14-day courses intermittently during the 6-month Maintenance Treatment Phase (ITT population). |
| 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 | The Percentage of Heartburn-free Days (24-hour Periods) During the 6-month Maintenance Treatment Phase (ITT Population). | The percentage of heartburn-free days during the 6-month Maintenance Treatment Phase in patients treated with rabeprazole 20 mg compared to patients who received placebo in the ITT Population. Heartburn-free day was defined as no heartburn in both the daytime and nighttime period on a given day. Note a total 388 subjects were enrolled at the beginning of Acute Phase and 200 subjects were enrolled into the double-blind 6-month maintenance treatment phase. | Intent-to-treat (ITT) population, total 187 subjects, was used for efficacy analyses. Safety population (total 200 subjects) was used for safety analysis and participant flow. | Posted | Mean | Standard Deviation | Percentage of Days | 6 months double-blind maintenance phase |
|
6 month maintenance phase
Safety population (total 200 subjects) was used for safety analysis and participant flow.
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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 | Rabeprazole 20 mg | Orally, once daily for 7- to 14-day courses intermittently during the 6-month Double-blind Maintenance Treatment Phase. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gallstone pancreatitis | Gastrointestinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yufang Lu, Study Director | Eisai Medical Research Inc. | 201-403-2500 |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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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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The percentage of heartburn-free nighttime period is presented cumulatively including all data collected during the 6-month |
| 6-month maintenance phase |
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Physician Decision |
|
| Protocol Violation |
|
| Other |
|
| Medication Noncompliance |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Placebo | Orally, once daily for 7 to 14-day courses intermittently during the 6-month Maintenance Treatment Phase (ITT population). |
|
|
|
| Secondary | The Percent of Heartburn-free Daytime Period During the 6-month Maintenance Treatment Phase | The percentage of heartburn-free daytime period is presented cumulatively including all data collected during the 6-month Maintenance Phase | Not Posted | Mean | Standard Deviation | % | 6-month maintenance phase |
| Secondary | The Percent of Heartburn-free Nighttime Period During the 6-month Maintenance Treatment Phase | The percentage of heartburn-free nighttime period is presented cumulatively including all data collected during the 6-month | Not Posted | Mean | Standard Deviation | % | 6-month maintenance phase |
| 2 |
| 38 |
| EG001 | Placebo | Orally, once daily for 7- to 14-day courses intermittently during the 6-month Double-blind Maintenance Treatment Phase. | 2 | 36 |
| Pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Chest pain | General disorders | Non-systematic Assessment |
|
| Schizoaffective disorder/depression | Nervous system disorders | Non-systematic Assessment |
|
| Erosive gastritis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Hiatus hernia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Esophageal erosion | Gastrointestinal disorders | Non-systematic Assessment |
|
| Esophagitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Viral gastroenteritis | Infections and infestations | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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| D004066 | Digestive System Diseases |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |