Reflux Esophagitis
Conditions
Keywords
Reflux Esophagitis
Brief summary
This study is to evaluate the efficacy of esomeprazole 20 mg once daily and 40 mg once daily for 8 weeks on healing of Reflux Esophagitis in patients with reflux esophagitis in comparison with omeprazole 20 mg once daily by assessment of presence/absence of Reflux Esophagitis at Week 8 according to the Los Angeles classification .
Interventions
DRUGEsomeprazole
20mg once daily
DRUGOmeprazole
20mg once daily
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Endoscopically verified Reflux Esophagitis classified into Los Angeles classification Grade A, B, C or D within 1 week before randomisation
Exclusion criteria
* Gastric or duodenal ulcer verified by EGD within 12 weeks before randomisation. * Use of any PPI from 14 days before EGD performed at the screening visit to the day of randomisation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded O at Week 8 Out of Patients Who Were Graded A, B, C or D at Baseline According to Los Angeles Classification. | 8 weeks | Los Angeles classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C, Grade D). The subjects who were definitely diagnosed to have RE classified into LA classification Grade A, B, C or D based on the EGD on Visit 1 were randomised. A subject classified into LA classification Grade O was considered no reflux esophagitis. The definitions of each grade are: Grade A (Mucosal break \< 5 mm in length), Grade B (Mucosal break \> 5mm), Grade C (Mucosal break continuous between \> 2 mucosal folds) and Grade D (Mucosal break \>75% of esophageal circumference). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded O at Week 4 Out of Patients Who Were Graded A, B, C or D at Baseline According to Los Angeles Classification | 4 weeks | Los Angeles classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). The subjects who were definitely diagnosed to have RE classified into LA classification Grade A, B, C or D based on the EGD on Visit 1 were randomised. A subject classified into LA classification Grade O was considered no reflux esophagitis. The definitions of each grade are: Grade A (Mucosal break \< 5 mm in length), Grade B (Mucosal break \> 5mm), Grade C (Mucosal break continuous between \> 2 mucosal folds) and Grade D (Mucosal break \>75% of esophageal circumference). |
Countries
Japan
Participant flow
Recruitment details
First subject enrolled on 11 December 2007. Last subject completed on 12 December 2008.
Pre-assignment details
Out of 602 enrolled subjects, 572 subjects were randomised and 30 subjects were not randomised. The reasons of no randomisation were 'Incorrect enrollment' (25 subjects) and 'Voluntary discontinuation by Subject' (5 subjects).
Participants by arm
| Arm | Count |
|---|---|
| Experimental: Esomeprazole 40mg Esomeprazole 40mg once daily | 191 |
| Experimental: Esomeprazole 20mg Esomeprazole 20mg once daily | 190 |
| Comparator: Omeprazole 20mg Omeprazole 20mg once daily | 191 |
| Total | 572 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 3 | 4 |
| Overall Study | Doctor's judgement | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 | 2 |
| Overall Study | Moved Away | 1 | 0 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 1 |
| Overall Study | Protocol Violation | 5 | 2 | 3 |
| Overall Study | Withdrawal by Subject | 3 | 9 | 1 |
Baseline characteristics
| Characteristic | Experimental: Esomeprazole 40mg | Experimental: Esomeprazole 20mg | Comparator: Omeprazole 20mg | Total |
|---|---|---|---|---|
| Age, Customized 65 - 74 years | 47 Participants | 36 Participants | 44 Participants | 127 Participants |
| Age, Customized < 65 years | 127 Participants | 135 Participants | 126 Participants | 388 Participants |
| Age, Customized >= 75 years | 16 Participants | 18 Participants | 20 Participants | 54 Participants |
| Age, Customized Missing | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Sex/Gender, Customized Female | 51 Participants | 52 Participants | 56 Participants | 159 Participants |
| Sex/Gender, Customized Male | 139 Participants | 137 Participants | 134 Participants | 410 Participants |
| Sex/Gender, Customized Missing | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 12 / 190 | 9 / 189 | 16 / 190 |
| serious Total, serious adverse events | 0 / 190 | 1 / 189 | 1 / 190 |
Outcome results
Primary
Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded O at Week 8 Out of Patients Who Were Graded A, B, C or D at Baseline According to Los Angeles Classification.
Los Angeles classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C, Grade D). The subjects who were definitely diagnosed to have RE classified into LA classification Grade A, B, C or D based on the EGD on Visit 1 were randomised. A subject classified into LA classification Grade O was considered no reflux esophagitis. The definitions of each grade are: Grade A (Mucosal break \< 5 mm in length), Grade B (Mucosal break \> 5mm), Grade C (Mucosal break continuous between \> 2 mucosal folds) and Grade D (Mucosal break \>75% of esophageal circumference).
Time frame: 8 weeks
Population: One participant for each treatment group did not take any investigational product. These 3 participants were excluded (1 for each treatment group) from all the efficacy and safety analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Esomeprazole 40mg | Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded O at Week 8 Out of Patients Who Were Graded A, B, C or D at Baseline According to Los Angeles Classification. | 171 participants |
| Experimental: Esomeprazole 20mg | Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded O at Week 8 Out of Patients Who Were Graded A, B, C or D at Baseline According to Los Angeles Classification. | 165 participants |
| Comparator: Omeprazole 20mg | Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded O at Week 8 Out of Patients Who Were Graded A, B, C or D at Baseline According to Los Angeles Classification. | 166 participants |
Secondary
Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded O at Week 4 Out of Patients Who Were Graded A, B, C or D at Baseline According to Los Angeles Classification
Los Angeles classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). The subjects who were definitely diagnosed to have RE classified into LA classification Grade A, B, C or D based on the EGD on Visit 1 were randomised. A subject classified into LA classification Grade O was considered no reflux esophagitis. The definitions of each grade are: Grade A (Mucosal break \< 5 mm in length), Grade B (Mucosal break \> 5mm), Grade C (Mucosal break continuous between \> 2 mucosal folds) and Grade D (Mucosal break \>75% of esophageal circumference).
Time frame: 4 weeks
Population: One participant for each treatment group did not take any investigational product. These 3 participants were excluded (1 for each treatment group) from all the efficacy and safety analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Esomeprazole 40mg | Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded O at Week 4 Out of Patients Who Were Graded A, B, C or D at Baseline According to Los Angeles Classification | 141 participants |
| Experimental: Esomeprazole 20mg | Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded O at Week 4 Out of Patients Who Were Graded A, B, C or D at Baseline According to Los Angeles Classification | 147 participants |
| Comparator: Omeprazole 20mg | Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded O at Week 4 Out of Patients Who Were Graded A, B, C or D at Baseline According to Los Angeles Classification | 143 participants |