Trial Outcomes & Findings for Rabeprazole Extended Release 50 mg Versus Ranitidine 150 mg for Maintenance of Healed Erosive Gastroesophageal Reflux Disease (GERD) (NCT NCT00839306)
NCT ID: NCT00839306
Last Updated: 2016-02-08
Results Overview
eGERD (erosive gastroesophageal reflux disease) healing measured by the Time-to-Relapse of Oesophageal Erosions using an Esophagogastroduodenoscopy (EGD). Lesions were identified and graded using the following Los Angeles (LA) classification of Oesophagitis: Not Present: No breaks (erosions) in the oesophageal 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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
240 participants
Primary outcome timeframe
Baseline to Week 26
Results posted on
2016-02-08
Participant Flow
Participants were eligible for this study if they had completed one of the healing studies (E3810-G000-302 or E3810-G000-303), had no evidence of oesophageal erosions, had sustained heartburn resolution, and had no record of any serious adverse event (SAE) related to study medication during the healing study.
Out of 240 participants who were randomized in this study, 237 participants received study treatment.
Participant milestones
| Measure |
RAN 150mg BID
Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
|
RAB ER 50mg QD
Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose included 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
177
|
|
Overall Study
COMPLETED
|
35
|
134
|
|
Overall Study
NOT COMPLETED
|
25
|
43
|
Reasons for withdrawal
| Measure |
RAN 150mg BID
Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
|
RAB ER 50mg QD
Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose included 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
5
|
|
Overall Study
Lost to Follow-up
|
6
|
9
|
|
Overall Study
Withdrawal by Subject
|
5
|
7
|
|
Overall Study
Lack of Efficacy
|
5
|
4
|
|
Overall Study
Other
|
6
|
18
|
Baseline Characteristics
Rabeprazole Extended Release 50 mg Versus Ranitidine 150 mg for Maintenance of Healed Erosive Gastroesophageal Reflux Disease (GERD)
Baseline characteristics by cohort
| Measure |
RAN 150mg BID
n=60 Participants
Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
|
RAB ER 50mg QD
n=177 Participants
Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose included 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
|
Total
n=237 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
47.5 Years
STANDARD_DEVIATION 13.55 • n=5 Participants
|
47.5 Years
STANDARD_DEVIATION 12.06 • n=7 Participants
|
47.5 Years
STANDARD_DEVIATION 12.43 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 26Population: Intent-to-Treat (ITT) Population - all randomized subjects who received at least 1 dose of study drug.
eGERD (erosive gastroesophageal reflux disease) healing measured by the Time-to-Relapse of Oesophageal Erosions using an Esophagogastroduodenoscopy (EGD). Lesions were identified and graded using the following Los Angeles (LA) classification of Oesophagitis: Not Present: No breaks (erosions) in the oesophageal 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.
Outcome measures
| Measure |
RAN 150mg BID
n=60 Participants
Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
|
RAB ER 50mg QD
n=177 Participants
Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose inlcuded 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
|
|---|---|---|
|
Percentage of Participants With Maintenance of Complete Healing of eGERD at Week 26
|
31.7 Percentage of Participants
|
88.4 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 26Population: ITT
Heartburn or other GERD-associated symptoms (regurgitation, epigastric or chest pain, dysphagia, belching, bloating, early satiety, other) was based on a 4-point Likert scale that included the following: None (No symptoms); Mild (Awareness of symptoms but easily tolerated); Moderate (Discomforting symptom sufficient to cause interference with normal activities including sleep); Severe (Incapacitating symptom, inability to perform normal activities).
Outcome measures
| Measure |
RAN 150mg BID
n=60 Participants
Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
|
RAB ER 50mg QD
n=177 Participants
Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose inlcuded 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
|
|---|---|---|
|
Percentage of Participants With Investigator-recorded Sustained Resolution of Heartburn at Week 26
Yes
|
8.3 Percentage of Participants
|
53.7 Percentage of Participants
|
|
Percentage of Participants With Investigator-recorded Sustained Resolution of Heartburn at Week 26
No
|
16.7 Percentage of Participants
|
17.5 Percentage of Participants
|
|
Percentage of Participants With Investigator-recorded Sustained Resolution of Heartburn at Week 26
Missing
|
75 Percentage of Participants
|
28.8 Percentage of Participants
|
Adverse Events
RAN 150mg BID
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
RAB ER 50mg QD
Serious events: 3 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RAN 150mg BID
n=56 participants at risk
Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
|
RAB ER 50mg QD
n=170 participants at risk
Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose included 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Pancreatitis
|
1.8%
1/56 • 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 30 weeks.
Data are presented as number of participants with treatment emergent adverse events (serious and nonserious). 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.
|
0.00%
0/170 • 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 30 weeks.
Data are presented as number of participants with treatment emergent adverse events (serious and nonserious). 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.
|
|
General disorders
Chest pain
|
0.00%
0/56 • 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 30 weeks.
Data are presented as number of participants with treatment emergent adverse events (serious and nonserious). 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.
|
0.59%
1/170 • 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 30 weeks.
Data are presented as number of participants with treatment emergent adverse events (serious and nonserious). 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.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/56 • 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 30 weeks.
Data are presented as number of participants with treatment emergent adverse events (serious and nonserious). 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.
|
0.59%
1/170 • 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 30 weeks.
Data are presented as number of participants with treatment emergent adverse events (serious and nonserious). 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.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/56 • 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 30 weeks.
Data are presented as number of participants with treatment emergent adverse events (serious and nonserious). 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.
|
0.59%
1/170 • 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 30 weeks.
Data are presented as number of participants with treatment emergent adverse events (serious and nonserious). 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.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/56 • 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 30 weeks.
Data are presented as number of participants with treatment emergent adverse events (serious and nonserious). 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.
|
0.59%
1/170 • 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 30 weeks.
Data are presented as number of participants with treatment emergent adverse events (serious and nonserious). 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.
|
Other adverse events
| Measure |
RAN 150mg BID
n=56 participants at risk
Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
|
RAB ER 50mg QD
n=170 participants at risk
Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose included 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Gastritis
|
7.1%
4/56 • 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 30 weeks.
Data are presented as number of participants with treatment emergent adverse events (serious and nonserious). 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.
|
10.0%
17/170 • 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 30 weeks.
Data are presented as number of participants with treatment emergent adverse events (serious and nonserious). 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.
|
|
Infections and infestations
Sinusitis
|
1.8%
1/56 • 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 30 weeks.
Data are presented as number of participants with treatment emergent adverse events (serious and nonserious). 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.
|
5.9%
10/170 • 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 30 weeks.
Data are presented as number of participants with treatment emergent adverse events (serious and nonserious). 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.
|
|
Gastrointestinal disorders
Hiatus hernia
|
10.7%
6/56 • 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 30 weeks.
Data are presented as number of participants with treatment emergent adverse events (serious and nonserious). 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.
|
4.1%
7/170 • 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 30 weeks.
Data are presented as number of participants with treatment emergent adverse events (serious and nonserious). 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.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.4%
3/56 • 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 30 weeks.
Data are presented as number of participants with treatment emergent adverse events (serious and nonserious). 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.
|
2.4%
4/170 • 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 30 weeks.
Data are presented as number of participants with treatment emergent adverse events (serious and nonserious). 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.
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
8.9%
5/56 • 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 30 weeks.
Data are presented as number of participants with treatment emergent adverse events (serious and nonserious). 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.
|
1.2%
2/170 • 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 30 weeks.
Data are presented as number of participants with treatment emergent adverse events (serious and nonserious). 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.
|
|
Gastrointestinal disorders
Acquired oesophageal web
|
5.4%
3/56 • 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 30 weeks.
Data are presented as number of participants with treatment emergent adverse events (serious and nonserious). 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.
|
1.2%
2/170 • 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 30 weeks.
Data are presented as number of participants with treatment emergent adverse events (serious and nonserious). 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.
|
Additional Information
Eisai Medical Services
Eisai Inc.
Phone: 888-422-4743
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place