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The purpose of this study is to investigate the efficacy and safety of Rabeprazole (RAB) Extended-Release (ER) 50 mg versus Esomeprazole (ESO) 40 mg in subjects with erosive gastroesophageal reflux disease (eGERD).
This is a multicenter, randomized, double-blind, double-dummy, parallel-group study. Subjects who meet all the inclusion/exclusion criteria will be randomly assigned to 1 of 2 treatment groups, Rabeprazole Extended-Release (RAB ER) 50 mg or Esomeprazole (ESO) 40 mg for the treatment of mild to moderate erosive Gastroesophageal Reflux Disease (GERD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rabeprazole sodium | Drug | Rabeprazole ER 50 mg capsule, once daily for 4-8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Erosive Gastroesophageal Reflux Disease (eGERD) Who Achieved Endoscopically-confirmed Healing by 8 Weeks | Healing at Week 4 or 8 were based on improvement of eGERD of the Los Angeles (LA) classification of esophagitis Grade A or B from Baseline. Classifications include: Not Present: No breaks (erosions) in the esophageal mucosa (however, edema, erythema, or friability may be present). Grade A: One or more mucosal breaks not more than 5mm in maximum length. Grade B: One or more mucosal breaks more than 5mm in maximum length, but not continuous between the tops of 2 mucosal folds. Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference. Gread D: Mucosal breaks involving at least 75% of the esophageal circumference. | Baseline and Week 8 |
| Percentage of Participants With eGERD Who Achieved Endoscopically-confirmed Healing by 4 Weeks | Healing at Week 4 or 8 were based on improvement of eGERD of the LA classification of esophagitis Grade A or B from Baseline. Classifications include: Not Present: No breaks (erosions) in the esophageal mucosa (however, edema, erythema, or friability may be present). Grade A: One or more mucosal breaks not more than 5mm in maximum length. Grade B: One or more mucosal breaks more than 5mm in maximum length, but not continuous between the tops of 2 mucosal folds. Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference. Gread D: Mucosal breaks involving at least 75% of the esophageal circumference. | Baseline and Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved Diary-recorded Sustained Resolution of Heartburn by Week 4 | During the first 4 weeks of the Double-blind Phase, participants were to record heartburn in a daily diary. Participant daily symptoms for the assessment of heartburn was based on a commonly used 4-point Likert scale of none, mild, moderate and severe. A participant was considered achieving sustained resolution of heartburn if the participant had maintained at least 7 consecutive heartburn-free days. |
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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 |
|---|---|---|---|---|---|---|
| Huntsville | Alabama | 35801 | United States | |||
Out of 1397 participants who were randomized, 1380 participants received study treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Esomeprazole (ESO) 40 mg | ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks. |
| FG001 | Rabeprazole (RAB) Extended Release (ER) 50 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Esomeprazole | Drug | Esomeprazole 40 mg capsule, once daily for 4-8 weeks. |
|
| Week 4 |
| Tucson |
| Arizona |
| 85712 |
| United States |
| Tucson | Arizona | 85741 | United States |
| Little Rock | Arkansas | 72205 | United States |
| Sherwood | Arkansas | 72120 | United States |
| Anaheim | California | 92801 | United States |
| Chula Vista | California | 91910 | United States |
| Fullerton | California | 92835 | United States |
| Irvine | California | 92618 | United States |
| Laguna Hills | California | 92653 | United States |
| Mission Hills | California | 91345 | United States |
| Redwood City | California | 94062 | United States |
| San Diego | California | 92123 | United States |
| San Louis Obispo | California | 93405 | United States |
| West Covina | California | 91790 | United States |
| Pueblo | Colorado | 81008 | United States |
| Wheat Ridge | Colorado | 80033 | United States |
| Bristol | Connecticut | 6010 | United States |
| Hartford | Connecticut | 6102 | United States |
| Boynton Beach | Florida | 33426 | United States |
| Hialeah | Florida | 33010 | United States |
| Hollywood | Florida | 33021 | United States |
| Jacksonville | Florida | 32256 | United States |
| Jupiter | Florida | 33458 | United States |
| Largo | Florida | 33777 | United States |
| Lauderdale Lakes | Florida | 33319 | United States |
| Naples | Florida | 34102 | United States |
| Orlando | Florida | 32806 | United States |
| Tampa | Florida | 33607 | United States |
| Tampa | Florida | 33613 | United States |
| Tampa | Florida | 33618 | United States |
| Newnan | Georgia | 30263 | United States |
| Rockford | Illinois | 61107 | United States |
| Clive | Iowa | 50325 | United States |
| Kansas City | Kansas | 66160 | United States |
| Topeka | Kansas | 66606 | United States |
| Louisville | Kentucky | 40202 | United States |
| Louisville | Kentucky | 40291 | United States |
| Baton Rouge | Louisiana | 70809 | United States |
| Slidell | Louisiana | 70458 | United States |
| Annapolis | Maryland | 21401 | United States |
| Hagerstown | Maryland | 21742 | United States |
| Mexico | Missouri | 65265 | United States |
| Washington | Missouri | 63090 | United States |
| Vineland | New Jersey | 8360 | United States |
| Albuquerque | New Mexico | 87106 | United States |
| Bay Shore | New York | 11706 | United States |
| Hartsdale | New York | 10530 | United States |
| Mineola | New York | 11501 | United States |
| New York | New York | 10021 | United States |
| Pittsford | New York | 14534 | United States |
| Boone | North Carolina | 28607 | United States |
| Chapel Hill | North Carolina | 27599 | United States |
| Charlotte | North Carolina | 28209 | United States |
| Jacksonville | North Carolina | 28546 | United States |
| New Bern | North Carolina | 28562 | United States |
| Wilmington | North Carolina | 28401 | United States |
| Fargo | North Dakota | 58104 | United States |
| Dayton | Ohio | 45415 | United States |
| Portland | Oregon | 97210 | United States |
| Portland | Oregon | 97220 | United States |
| Portland | Oregon | 97225 | United States |
| Anderson | South Carolina | 29621 | United States |
| Charleston | South Carolina | 29414 | United States |
| Columbia | South Carolina | 29203 | United States |
| Franklin | Tennessee | 37067 | United States |
| Germantown | Tennessee | 38138 | United States |
| Jackson | Tennessee | 38301 | United States |
| Johnson City | Tennessee | 37604 | United States |
| Kingsport | Tennessee | 37660 | United States |
| Nashville | Tennessee | 37203 | United States |
| Nashville | Tennessee | 37211 | United States |
| Beaumont | Texas | 77701 | United States |
| Bryan | Texas | 77802 | United States |
| Dallas | Texas | 75231 | United States |
| Fort Worth | Texas | 76104 | United States |
| Houston | Texas | 77079 | United States |
| San Antonio | Texas | 78229 | United States |
| Chesapeake | Virginia | 23320 | United States |
| Bellevue | Washington | 98004 | United States |
| Spokane | Washington | 92204-2318 | United States |
| Spokane | Washington | 99216 | United States |
| Madison | Wisconsin | 53715 | United States |
| Milwaukee | Wisconsin | 53209 | United States |
| Milwaukee | Wisconsin | 53215 | United States |
RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
| COMPLETED |
|
| NOT COMPLETED |
|
|
The analysis was performed using the Intent-to-Treat (ITT) population, defined as all randomized subjects who received at least 1 dose of study drug, minus two participants from one site who were excluded from the ITT Population per an agreement with the FDA due to concerns of possible misconduct.
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| ID | Title | Description |
|---|---|---|
| BG000 | ESO 40 mg | ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks. |
| BG001 | RAB ER 50 mg | RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Percentage of Participants Who Achieved Diary-recorded Sustained Resolution of Heartburn by Week 4 | During the first 4 weeks of the Double-blind Phase, participants were to record heartburn in a daily diary. Participant daily symptoms for the assessment of heartburn was based on a commonly used 4-point Likert scale of none, mild, moderate and severe. A participant was considered achieving sustained resolution of heartburn if the participant had maintained at least 7 consecutive heartburn-free days. | The analysis was performed using the ITT population, defined as all randomized subjects who received at least 1 dose of study drug, minus two participants from one site who were excluded from the ITT Population per an agreement with the FDA due to concerns of possible misconduct. | Posted | Number | Percentage of Participants | Week 4 |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Erosive Gastroesophageal Reflux Disease (eGERD) Who Achieved Endoscopically-confirmed Healing by 8 Weeks | Healing at Week 4 or 8 were based on improvement of eGERD of the Los Angeles (LA) classification of esophagitis Grade A or B from Baseline. Classifications include: Not Present: No breaks (erosions) in the esophageal mucosa (however, edema, erythema, or friability may be present). Grade A: One or more mucosal breaks not more than 5mm in maximum length. Grade B: One or more mucosal breaks more than 5mm in maximum length, but not continuous between the tops of 2 mucosal folds. Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference. Gread D: Mucosal breaks involving at least 75% of the esophageal circumference. | The analysis was performed using the Intent-to-Treat (ITT) population, defined as all randomized subjects who received at least 1 dose of study drug, minus two participants from one site who were excluded from the ITT Population per an agreement with the FDA due to concerns of possible misconduct. | Posted | Number | Percentage of Participants | Baseline and Week 8 |
| ||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With eGERD Who Achieved Endoscopically-confirmed Healing by 4 Weeks | Healing at Week 4 or 8 were based on improvement of eGERD of the LA classification of esophagitis Grade A or B from Baseline. Classifications include: Not Present: No breaks (erosions) in the esophageal mucosa (however, edema, erythema, or friability may be present). Grade A: One or more mucosal breaks not more than 5mm in maximum length. Grade B: One or more mucosal breaks more than 5mm in maximum length, but not continuous between the tops of 2 mucosal folds. Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference. Gread D: Mucosal breaks involving at least 75% of the esophageal circumference. | The analysis was performed using the ITT population, defined as all randomized subjects who received at least 1 dose of study drug, minus two participants from one site who were excluded from the ITT Population per an agreement with the FDA due to concerns of possible misconduct. | Posted | Number | Percentage of Participants | Baseline and Week 4 |
|
For each participant, from the time of administration of the first dose of study drug up to 30 days after the administration of the last dose of study drug or up to resolution of adverse event or up to approximately 10 weeks.
Data are presented as number of participants with treatment emergent adverse events. The analysis was performed using the Safety Analysis Set (SAS), defined as all subjects who received at least 1 dose of study drug and had a postbaseline safety assessment.
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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 | ESO 40 mg | ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks. | 6 | 676 | 0 | 676 | ||
| EG001 | RAB ER 50 mg | RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks. | 3 | 685 | 0 | 685 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute coronary syndrome | Cardiac disorders | MedDRA Version 11.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA Version 11.1 | Systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA Version 11.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA Version 11.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 11.1 | Systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 11.1 | Systematic Assessment |
| |
| Neuroendocrine carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 11.1 | Systematic Assessment |
| |
| Rectosigmoid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 11.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 11.1 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA Version 11.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.1 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eisai Medical Services | Eisai Inc. | 888-422-4743 |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D064750 | Rabeprazole |
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D009853 | Omeprazole |
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| Male |
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| Missing |
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