Reflux Esophagitis
Conditions
Keywords
Reflux Esophagitis
Brief summary
The primary objective of this study is to evaluate the efficacy of esomeprazole 20 mg once daily for 24 weeks on maintenance of Reflux Esophagitis in patients with healed reflux esophagitis in comparison with omeprazole 10 mg once daily and esomeprazole 10 mg once daily by assessment of presence/absence of recurrence of Reflux Esophagitis throughout the treatment period (from the randomisation to the treatment completion) according to the Los Angeles classification.
Interventions
DRUGEsomeprazole
10mg once daily oral administration
DRUGOmeprazole
10mg once daily oral administration
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
* Patients with healed Reflux Esophagitis verified by EGD in the preceding study (D961HC00002) * Patients with endoscopically verified healed Reflux Esophagitis by EGD receiving general treatment with PPI
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 |
|---|---|---|
| Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification Throughout the Treatment Period. | Up to 24 weeks | Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D throughout the treatment period was evaluated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 4 Weeks After Treatment | up to 4 weeks | Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D up to 4 weeks after treatment was evaluated. |
| Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 12 Weeks After Treatment | Up to 12 weeks | Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D up to 12 weeks after treatment was evaluated. |
Countries
Japan
Participant flow
Recruitment details
Enrolment 8Jan08-19May09. 564 randomised participants, 563 in Full Analysis set and safety analysis set. FAS used for summaries of baseline characteristics and efficacy. SAS for summaries of safety. 1 pt. in Omep. 10 mg excluded as they took no investigational drug. Nos. for gender were 188 in Esom. 20 mg, 188 in Esom. 10 mg and 187 in Omep. 20 mg.
Pre-assignment details
Out of 578 enrolled participants, 564 participants were randomised and 14 participants were not randomised. The reasons of no randomisation were 'Incorrect enrolment' (11 participants) and 'Voluntary discontinuation by participant' (3 participants).
Participants by arm
| Arm | Count |
|---|---|
| Experimental: Esomeprazole 20 mg Esomeprazole 20 mg once daily | 188 |
| Experimental: Esomeprazole 10 mg Esomeprazole 10 mg once daily | 189 |
| Comparator: Omeprazole 10 mg Omeprazole 10 mg once daily | 187 |
| Total | 564 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 6 | 8 | 3 |
| Overall Study | Difficult to continue | 3 | 1 | 1 |
| Overall Study | Incorrect enrolment | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 |
| Overall Study | Other reason | 1 | 1 | 1 |
| Overall Study | Pregnancy | 1 | 0 | 0 |
| Overall Study | Protocol Violation | 3 | 3 | 1 |
| Overall Study | Recurrence of reflux esophagitis | 5 | 15 | 21 |
| Overall Study | Withdrawal by Subject | 9 | 6 | 11 |
Baseline characteristics
| Characteristic | Experimental: Esomeprazole 20 mg | Experimental: Esomeprazole 10 mg | Comparator: Omeprazole 10 mg | Total |
|---|---|---|---|---|
| Age, Customized <65 | 131 Participants | 131 Participants | 137 Participants | 399 Participants |
| Age, Customized 65-74 | 45 Participants | 41 Participants | 38 Participants | 124 Participants |
| Age, Customized >=75 | 12 Participants | 16 Participants | 12 Participants | 40 Participants |
| Age, Customized Missing | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Sex/Gender, Customized Female | 46 Participants | 51 Participants | 42 Participants | 139 Participants |
| Sex/Gender, Customized Male | 142 Participants | 147 Participants | 145 Participants | 434 Participants |
| Sex/Gender, Customized Missing | 0 Participants | 1 Participants | 0 Participants | 1 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 | 71 / 188 | 69 / 188 | 34 / 187 |
| serious Total, serious adverse events | 5 / 188 | 4 / 188 | 1 / 187 |
Outcome results
Primary
Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification Throughout the Treatment Period.
Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D throughout the treatment period was evaluated.
Time frame: Up to 24 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Esomeprazole 20 mg | Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification Throughout the Treatment Period. | 174 Participants |
| Experimental: Esomeprazole 10 mg | Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification Throughout the Treatment Period. | 166 Participants |
| Comparator: Omeprazole 10 mg | Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification Throughout the Treatment Period. | 156 Participants |
Secondary
Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 12 Weeks After Treatment
Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D up to 12 weeks after treatment was evaluated.
Time frame: Up to 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Esomeprazole 20 mg | Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 12 Weeks After Treatment | 179 Participants |
| Experimental: Esomeprazole 10 mg | Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 12 Weeks After Treatment | 172 Participants |
| Comparator: Omeprazole 10 mg | Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 12 Weeks After Treatment | 163 Participants |
Secondary
Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 4 Weeks After Treatment
Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D up to 4 weeks after treatment was evaluated.
Time frame: up to 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Esomeprazole 20 mg | Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 4 Weeks After Treatment | 184 Participants |
| Experimental: Esomeprazole 10 mg | Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 4 Weeks After Treatment | 180 Participants |
| Comparator: Omeprazole 10 mg | Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 4 Weeks After Treatment | 171 Participants |