Trial Outcomes & Findings for Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Moderate to Severe Erosive Gastroesophageal Reflux Disease (GERD) (NCT NCT00658528)
NCT ID: NCT00658528
Last Updated: 2015-12-21
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1061 participants
Primary outcome timeframe
Baseline and Week 8
Results posted on
2015-12-21
Participant Flow
Out of 1061 participants who were randomized, 1055 participants received study treatment.
Participant milestones
| Measure |
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.
|
RAB ER 50 mg
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.
|
|---|---|---|
|
Overall Study
STARTED
|
531
|
524
|
|
Overall Study
COMPLETED
|
491
|
479
|
|
Overall Study
NOT COMPLETED
|
40
|
45
|
Reasons for withdrawal
| Measure |
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.
|
RAB ER 50 mg
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
7
|
|
Overall Study
Lost to Follow-up
|
14
|
22
|
|
Overall Study
Withdrawal by Subject
|
8
|
6
|
|
Overall Study
Withdrawal of consent
|
5
|
6
|
|
Overall Study
Other
|
8
|
4
|
Baseline Characteristics
Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Moderate to Severe Erosive Gastroesophageal Reflux Disease (GERD)
Baseline characteristics by cohort
| Measure |
ESO 40 mg
n=531 Participants
ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
|
RAB ER 50 mg
n=524 Participants
RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
|
Total
n=1055 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49 Years
STANDARD_DEVIATION 13.09 • n=5 Participants
|
48 Years
STANDARD_DEVIATION 13.38 • n=7 Participants
|
48.5 Years
STANDARD_DEVIATION 13.23 • n=5 Participants
|
|
Sex: Female, Male
Female
|
206 Participants
n=5 Participants
|
202 Participants
n=7 Participants
|
408 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
325 Participants
n=5 Participants
|
322 Participants
n=7 Participants
|
647 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 8Population: Intent-to-Treat (ITT) Population - all randomized participants who received at least 1 dose of study drug.
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.
Outcome measures
| Measure |
ESO 40 mg
n=531 Participants
ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
|
RAB ER 50 mg
n=524 Participants
RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
|
|---|---|---|
|
Percentage of Participants With Erosive Gastroesophageal Reflux Disease (eGERD) Who Achieved Endoscopically-confirmed Healing by 8 Weeks
Yes
|
75 Percentage of Participants
|
80 Percentage of Participants
|
|
Percentage of Participants With Erosive Gastroesophageal Reflux Disease (eGERD) Who Achieved Endoscopically-confirmed Healing by 8 Weeks
No
|
20.3 Percentage of Participants
|
14.9 Percentage of Participants
|
|
Percentage of Participants With Erosive Gastroesophageal Reflux Disease (eGERD) Who Achieved Endoscopically-confirmed Healing by 8 Weeks
Missing
|
4.7 Percentage of Participants
|
5.2 Percentage of Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 4Population: ITT Population
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.
Outcome measures
| Measure |
ESO 40 mg
n=531 Participants
ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
|
RAB ER 50 mg
n=524 Participants
RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
|
|---|---|---|
|
Percentage of Participants With eGERD Who Achieved Endoscopically-confirmed Healing by 4 Weeks
Missing
|
1.9 Percentage of Participants
|
2.7 Percentage of Participants
|
|
Percentage of Participants With eGERD Who Achieved Endoscopically-confirmed Healing by 4 Weeks
Yes
|
50.3 Percentage of Participants
|
54.8 Percentage of Participants
|
|
Percentage of Participants With eGERD Who Achieved Endoscopically-confirmed Healing by 4 Weeks
No
|
47.8 Percentage of Participants
|
42.6 Percentage of Participants
|
SECONDARY outcome
Timeframe: Week 4Population: ITT Population
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.
Outcome measures
| Measure |
ESO 40 mg
n=531 Participants
ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
|
RAB ER 50 mg
n=524 Participants
RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
|
|---|---|---|
|
Percentage of Participants Who Achieved Diary-recorded Sustained Resolution of Heartburn by Week 4
Yes
|
48.2 Percentage of Participants
|
48.3 Percentage of Participants
|
|
Percentage of Participants Who Achieved Diary-recorded Sustained Resolution of Heartburn by Week 4
No
|
46.3 Percentage of Participants
|
44.3 Percentage of Participants
|
|
Percentage of Participants Who Achieved Diary-recorded Sustained Resolution of Heartburn by Week 4
Missing
|
5.5 Percentage of Participants
|
7.4 Percentage of Participants
|
Adverse Events
ESO 40 mg
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
RAB ER 50 mg
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ESO 40 mg
n=528 participants at risk
ESO 40 mg capsule concurrently with placebo (identical in appearance to the RAB ER 50 mg capsule), once daily for 4 to 8 weeks.
|
RAB ER 50 mg
n=518 participants at risk
RAB ER 50 mg capsule concurrently with placebo (identical in appearance to the ESO 40 mg capsule), once daily for 4 to 8 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.19%
1/528 • 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.
|
0.00%
0/518 • 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.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/528 • 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.
|
0.19%
1/518 • 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.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/528 • 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.
|
0.19%
1/518 • 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.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/528 • 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.
|
0.19%
1/518 • 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.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/528 • 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.
|
0.19%
1/518 • 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.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.19%
1/528 • 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.
|
0.00%
0/518 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.19%
1/528 • 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.
|
0.00%
0/518 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
|
0.19%
1/528 • 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.
|
0.00%
0/518 • 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.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/528 • 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.
|
0.19%
1/518 • 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.
|
Other adverse events
Adverse event data not reported
Additional Information
Eisai Inc.
Eisai Call Center
Phone: 888-422-4743
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place