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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-006046-17 | EudraCT Number |
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The purpose of this study is to investigate the efficacy (ie, healing and symptom relief) and safety of Rabeprazole Extended-Release (RAB ER) 50 mg versus Esomeprazole (ESO) 40 mg for the treatment of moderate to severe 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 moderate to severe erosive Gastroesophageal Reflux Disease (eGERD).
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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 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 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. Grade 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 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. 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 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 |
|---|---|---|---|---|---|---|
| Moline | Illinois | 61265 | 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 1069 participants who were randomized, 1065 participants received study treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | ESO 40mg | Esomeprazole (ESO) 40mg capsule concurrently with placebo (identical in appearance to the RAB Extended Release (ER) 50mg capsule), once daily for 4 to 8 weeks. |
| FG001 | RAB ER 50mg |
| 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 |
| La Plata |
| Argentina |
| 1900 |
| Argentina |
| Buenos Aires | BUE | B1832BQS | Argentina |
| Buenos Aires | BUE | C1117ABK | Argentina |
| Ciudad Autonoma de Bs. As. | CBA | 1431 | Argentina |
| Ciudad Autonoma de Bs. As. | CBA | C1120AAT | Argentina |
| Ciudad Autonoma de Bs. As. | CBA | C1181ACH | Argentina |
| Rosario | SFE | 2000 | Argentina |
| San Miguel de Tucumán | TUC | 4000 | Argentina |
| Penrith | New South Wales | 2751 | Australia |
| Caboolture | Queensland | 4510 | Australia |
| Adelaide | South Australia | 5001 | Australia |
| Woodville | South Australia | 5011 | Australia |
| Launceston | Tasmania | 7250 | Australia |
| Ballarat | Victoria | 3353 | Australia |
| Fitzroy | Victoria | 3065 | Australia |
| Haskovo | Bulgaria | 6300 | Bulgaria |
| Plovdiv | Bulgaria | 4000 | Bulgaria |
| Rousse | Bulgaria | 7002 | Bulgaria |
| Sofia | Bulgaria | 1527 | Bulgaria |
| Sofia | Bulgaria | 1606 | Bulgaria |
| Barrie | Ontario | L4M 7G1 | Canada |
| Chatham | Ontario | N7L 1B9 | Canada |
| Hamilton | Ontario | L8V 1C3 | Canada |
| Richmond Hill | Ontario | L4B 3P8 | Canada |
| Sarnia | Ontario | N7T 4X3 | Canada |
| Toronto | Ontario | M3J 1N2 | Canada |
| Toronto | Ontario | M3N 2V7 | Canada |
| Toronto | Ontario | M4P 1P2 | Canada |
| Toronto | Ontario | M9W 4L6 | Canada |
| Sherbrooke | Quebec | J1G 2E8 | Canada |
| Saskatoon | Saskatchewan | S7K 1N4 | Canada |
| Providencia | Chile | Chile |
| Santiago | Chile | Chile |
| Temuco | Chile | Chile |
| Osijek | Croatia | 31 000 | Croatia |
| Split | Croatia | 21 000 | Croatia |
| Zagreb | Croatia | 10 000 | Croatia |
| Tallinn | Estonia | 10138 | Estonia |
| Tallinn | Estonia | 10617 | Estonia |
| Saint-Quentin | France | 2100 | France |
| Lyon | Lyonnais | 69437 | France |
| Marseille | Provence | 13015 | France |
| Freising | Bavaria | 85356 | Germany |
| Potsdam | BR | 14482 | Germany |
| Herne | North Rhine-Westphalia | 44623 | Germany |
| Münster | North Rhine-Westphalia | 48167 | Germany |
| Ludwigshafen am Rhein | Rhineland-Palatinate | 67067 | Germany |
| Mainz | Rhineland-Palatinate | 55131 | Germany |
| Dresden | Saxony | 1307 | Germany |
| Wolmirstedt | Saxony-Anhalt | 39326 | Germany |
| Balatonfüred | Hungary | 8230 | Hungary |
| Budapest | Hungary | 1088 | Hungary |
| Budapest | Hungary | 1201 | Hungary |
| Debrecen | Hungary | 4032 | Hungary |
| Eger | Hungary | 3300 | Hungary |
| Győr | Hungary | 9024 | Hungary |
| Gyula | Hungary | 5700 | Hungary |
| Kaposvár | Hungary | 7400 | Hungary |
| Pécs | Hungary | 7624 | Hungary |
| Siófok | Hungary | 8601 | Hungary |
| Szekszárd | Hungary | 7100 | Hungary |
| Hyderabad | Andhra Pradesh | 500 082 | India |
| Hyderabad | Andhra Pradesh | 500001 | India |
| Hyderabad | Andhra Pradesh | 500004 | India |
| Hyderabad | Andhra Pradesh | 500012 | India |
| Hyderabad | Andhra Pradesh | 500063 | India |
| Hyderabad | Andhra Pradesh | 500082 | India |
| Secunderabad | Andhra Pradesh | 500003 | India |
| Visakhapatnam | Andhra Pradesh | 53002 | India |
| Bangalore | Karnataka | 560054 | India |
| Mangalore | Karnataka | 575001 | India |
| Kochi | Kerala | 682304 | India |
| New Delhi | National Capital Territory of Delhi | 110029 | India |
| Ludhiana | Punjab | 141001 | India |
| Chennai | Tamil Nadu | 600096 | India |
| Madurai | Tamil Nadu | 625002 | India |
| Balvi | Latvia | LV-4501 | Latvia |
| Daugavpils | Latvia | LV-5417 | Latvia |
| Riga | Latvia | LV-1006 | Latvia |
| Å iauliai | Lithuania | LT-76231 | Lithuania |
| Vilnius | Lithuania | 3215 | Lithuania |
| Vilnius | Lithuania | LT-08661 | Lithuania |
Rabeprazole (RAB) Extended Release (ER) 50mg capsule concurrently with placebo (identical in appearance to the ESO 40mg capsule), once daily for 4 to 8 weeks.
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ESO 40mg | Esomeprazole (ESO) 40mg capsule concurrently with placebo (identical in appearance to the RAB Extended Release (ER) 50mg capsule), once daily for 4 to 8 weeks. |
| BG001 | RAB ER 50mg | Rabeprazole (RAB) Extended Release (ER) 50mg capsule concurrently with placebo (identical in appearance to the ESO 40mg 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. | ITT Population | Posted | Number | Percentage of Participants | Week 4 |
|
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| ||||||||||||||||||||||||||||||||||||
| 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 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. Grade D: Mucosal breaks involving at least 75% of the esophageal circumference. | ITT Population - all randomized subjects 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 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. 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 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 (serious and nonserious). 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 40mg | Esomeprazole (ESO) 40mg capsule concurrently with placebo (identical in appearance to the RAB Extended Release (ER) 50mg capsule), once daily for 4 to 8 weeks. | 3 | 532 | 0 | 532 | ||
| EG001 | RAB ER 50mg | Rabeprazole (RAB) Extended Release (ER) 50mg capsule concurrently with placebo (identical in appearance to the ESO 40mg capsule), once daily for 4 to 8 weeks. | 3 | 526 | 0 | 526 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oesophageal stenosis | Gastrointestinal disorders | MedDRA Version 11.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA Version 11.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 11.1 | Systematic Assessment |
| |
| Pneumonia primary atypical | Infections and infestations | MedDRA Version 11.1 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | 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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| Units |
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| Counts |
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| Participants |
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