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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-005570-32 | EudraCT Number |
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The purpose of this study is to determine the safety and efficacy of Rabeprazole extended release (ER) 50 mg versus Esomeprazole 40 mg for healing and symptomatic relief among subjects with erosive gastroesophageal reflux disease (GERD).
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 ER 50 mg or Esomeprazole 40 mg for the treatment of moderate to severe erosive 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, taken orally, 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 C or D 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 5 mm in maximum length. Grade B: One or more mucosal breaks more than 5 mm 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 C or D 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 5 mm in maximum length. Grade B: One or more mucosal breaks more than 5 mm 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. Grade 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 hearburn 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, MD, PhD | Eisai Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim | California | 92801 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21114792 | Derived | Laine L, Katz PO, Johnson DA, Ibegbu I, Goldstein MJ, Chou C, Rossiter G, Lu Y. Randomised clinical trial: a novel rabeprazole extended release 50 mg formulation vs. esomeprazole 40 mg in healing of moderate-to-severe erosive oesophagitis - the results of two double-blind studies. Aliment Pharmacol Ther. 2011 Jan;33(2):203-12. doi: 10.1111/j.1365-2036.2010.04516.x. Epub 2010 Nov 30. |
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Out of 1061 participants who were randomized, 1055 participants received study treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | ESO 40 mg | Esomeprazole (ESO) 40 mg capsule concurrently with placebo (identical in appearance to the RAB Extended Release (ER) 50 mg capsule), once daily for 4 to 8 weeks. |
| FG001 | RAB ER 50 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Esomeprazole | Drug | Esomeprazole 40 mg capsule, taken orally, once daily for 4-8 weeks. |
|
| Week 4 |
| Isidro Casanova, La Matanza |
| BUE |
| 1765 |
| Argentina |
| Ramos MejÃa | BUE | 1221 | Argentina |
| San Isidro | BUE | B1642BHH | Argentina |
| Capital Federal | CBA | C1425DND | Argentina |
| Mendoza | MEN | 5500 | Argentina |
| Rosario | SFE | S2000BLG | Argentina |
| Rosario | SFE | S2000CRF | Argentina |
| Rosario | SFE | S2000CVB | Argentina |
| San Juan | SJN | 5447 | Argentina |
| Five Dock | New South Wales | 2046 | Australia |
| Carina Heights | Queensland | 4152 | Australia |
| Kippa-Ring | Queensland | 4021 | Australia |
| Box Hill | Victoria | 3128 | Australia |
| Frankston | Victoria | 3199 | Australia |
| Malvern | Victoria | 3144 | Australia |
| Plovdiv | Bulgaria | 4000 | Bulgaria |
| Sofia | Bulgaria | 1233 | Bulgaria |
| Sofia | Bulgaria | 1407 | Bulgaria |
| Sofia | Bulgaria | 1431 | Bulgaria |
| Sofia | Bulgaria | 1709 | Bulgaria |
| Stara Zagora | Bulgaria | 6000 | Bulgaria |
| Varna | Bulgaria | 9010 | Bulgaria |
| Saint John | New Brunswick | E2K 1J5 | Canada |
| St. John's | Newfoundland and Labrador | A1A 3R5 | Canada |
| Guelph | Ontario | N1H 3R3 | Canada |
| Hamilton | Ontario | L8N 3Z5 | Canada |
| Newmarket | Ontario | L3Y 5G8 | Canada |
| Toronto | Ontario | M6H 3M1 | Canada |
| Windsor | Ontario | N8W 1E6 | Canada |
| Montreal | Quebec | H1T 2M4 | Canada |
| Montreal | Quebec | H3A 1A1 | Canada |
| Pointe-Claire | Quebec | H9R 3J1 | Canada |
| Québec | Quebec | G1L 3L5 | Canada |
| Québec | Quebec | G1R 2J6 | Canada |
| Saskatoon | Saskatchewan | S7K 1J5 | Canada |
| Santiago | Chile | Chile |
| Vioa Del Mar | Chile | Chile |
| Rijeka | Croatia | 51 000 | Croatia |
| Zagreb | Croatia | 10 000 | Croatia |
| Tartu | Estonia | 51014 | Estonia |
| Dieppe | France | 76200 | France |
| La Chaussée-Saint-Victor | France | 41260 | France |
| Lyon | France | 69437 | France |
| Marseille 13 | France | 13009 | France |
| Nice | France | 6100 | France |
| Mannheim | Baden-Wurttemberg | 68167 | Germany |
| Munich | Bavaria | 81669 | Germany |
| Hamburg | Free and Hanseatic City of Hamburg | 22143 | Germany |
| Dietzenbach | Hesse | 63128 | Germany |
| Marburg | Hesse | 35033 | Germany |
| Wiesbaden | Hesse | 65185 | Germany |
| Dortmund | North Rhine-Westphalia | 44137 | Germany |
| Lienen/Kattenve Nne | North Rhine-Westphalia | 49536 | Germany |
| Münster | North Rhine-Westphalia | 48159 | Germany |
| Berlin | State of Berlin | 10967 | Germany |
| Berlin | State of Berlin | 13509 | Germany |
| Budapest | Hungary | 1036 | Hungary |
| Dunaújváros | Hungary | 2400 | Hungary |
| Kisbér | Hungary | 2870 | Hungary |
| Miskolc | Hungary | 3530 | Hungary |
| Nagykanizsa | Hungary | 8800 | Hungary |
| NyÃregyháza | Hungary | 4400 | Hungary |
| Szentes | Hungary | 6600 | Hungary |
| Veszprém | Hungary | 8200 | Hungary |
| Zalaegerszeg | Hungary | 8900 | Hungary |
| Ahmedabad | Gujarat | 380006 | India |
| Manipal | Karnataka | 576104 | India |
| Bhopal | Madhya Pradesh | 462038 | India |
| Aurangabad | Maharashtra | 431005 | India |
| Mumbai | Maharashtra | 400 022 | India |
| Mumbai | Maharashtra | 400012 | India |
| Mumbai | Maharashtra | 400016 | India |
| Mumbai | Maharashtra | 400020 | India |
| Nagpur | Maharashtra | 440012 | India |
| Pune | Maharashtra | 411001 | India |
| Pune | Maharashtra | 411004 | India |
| Pune | Maharashtra | PUNE-411013 | India |
| Thane | Maharashtra | 400001 | India |
| New Delhi | National Capital Territory of Delhi | 110 060 | India |
| New Delhi | National Capital Territory of Delhi | 110002 | India |
| New Delhi | National Capital Territory of Delhi | 110017 | India |
| Ludhiana | Punjab | 141008 | India |
| Jaipur | Rajasthan | 302001 | India |
| Jaipur | Rajasthan | 302004 | India |
| Lucknow | Uttar Pradesh | 226003 | India |
| Riga | Latvia | LV-1002 | Latvia |
| Riga | Latvia | LV-1005 | Latvia |
Rabeprazole (RAB) Extended Release (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 |
|
|
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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 hearburn 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. | ITT Population | 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 C or D 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 5 mm in maximum length. Grade B: One or more mucosal breaks more than 5 mm 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. | Intent-to-Treat (ITT) Population - all randomized participants who received at least 1 dose of study drug. | 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 C or D 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 5 mm in maximum length. Grade B: One or more mucosal breaks more than 5 mm 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. Grade D: Mucosal breaks involving at least 75% of the esophageal circumference. | ITT Population | Posted | Number | Percentage of Participants | Baseline and Week 4 |
|
|
For each participant, from the time of administartion 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 (serious and non-serious). The analysis was performed using 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. | 4 | 528 | 0 | 528 | ||
| 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. | 4 | 518 | 0 | 518 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 11.1 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA Version 11.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA Version 11.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA Version 11.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA Version 11.1 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA Version 11.1 | Systematic Assessment |
| |
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 11.1 | Systematic Assessment |
| |
| Ovarian adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 11.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA Version 11.1 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eisai Inc. | Eisai Call Center | 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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| Units | Counts |
|---|---|
| Participants |
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| Counts |
|---|
| Participants |
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