Duodenal Ulcer, Gastric Ulcer, Lumbago, Osteoarthritis, Rheumatoid Arthritis
Conditions
Keywords
gastrointestinal, GI, NSAID, Japan, Japanese, Gastric ulcer, duodenal ulcer
Brief summary
The purpose of this study is to assess the efficacy of esomeprazole (D961H) 20 mg versus placebo once daily for up to 24 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID) therapy by evaluating presence or absence of gastric and/or duodenal ulcers throughout the treatment period (24 weeks) in terms of efficacy on prevention of gastric and/or duodenal ulcers
Interventions
DRUGEsomeprazole
20mg once daily oral
DRUGPlacebo
once daily oral
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Medical history of gastric and/or duodenal ulcer * A diagnosis of a chronic condition (rheumatoid arthritis, osteoarthritis, lumbago,etc) that requires daily NSAID use,at least 20 years of age
Exclusion criteria
* Having gastric or duodenal ulcer in active or healing stage according to the Sakita/Miwa classification * History of esophageal, gastric or duodenal surgery * Having severe liver disease or chronic renal disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absence of Gastric and/or Duodenal Ulcer Throughout the Treatment Period | each visit up to 24 weeks | The absence of gastric and/or duodenal ulcer throughout the treatment period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Absence of Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment | up to 4 weeks | The absence of gastric and/or duodenal ulcer up to 4 weeks after treatment |
| Absence of Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment | up to 12 weeks | The absence of gastric and/or duodenal ulcer up to 12 weeks after treatment |
Countries
Japan
Participant flow
Recruitment details
343 randomised participants 341 in Full Analysis set and safety analysis set. Full set used for summaries of baseline char. and efficacy variables. Safety set used for summaries of safety variables. 2 excluded, took no investigational drug or had protocol deviation. 173 Esomeprazole 20 and 168 placebo had baseline information and were summarised.
Pre-assignment details
Out of 1246 enrolled participants, 343 participants were randomised and 903 participants were not randomised. The major reasons of no randomisation were 'Did not meet eligibility criteria' (877 participants) and 'Voluntary discontinuation by participant' (24 participants).
Participants by arm
| Arm | Count |
|---|---|
| Experimental: Esomeprazole 20 mg Esomeprazole 20 mg once daily oral | 175 |
| Comparater: Placebo Placebo once daily oral | 168 |
| Total | 343 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 18 | 17 |
| Overall Study | Protocol Violation | 8 | 1 |
| Overall Study | Recurrence of Gastric Ulcer | 8 | 57 |
| Overall Study | Withdrawal by Subject | 7 | 3 |
Baseline characteristics
| Characteristic | Comparater: Placebo | Experimental: Esomeprazole 20 mg | Total |
|---|---|---|---|
| Age, Customized <65 years | 91 participants | 78 participants | 169 participants |
| Age, Customized >=75 years | 23 participants | 36 participants | 59 participants |
| Age, Customized Between 65 and 74 years | 54 participants | 59 participants | 113 participants |
| Age, Customized Missing | 0 participants | 2 participants | 2 participants |
| Sex/Gender, Customized Female | 100 participants | 108 participants | 208 participants |
| Sex/Gender, Customized Male | 68 participants | 65 participants | 133 participants |
| Sex/Gender, Customized Missing | 0 participants | 2 participants | 2 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 134 / 173 | 124 / 168 |
| serious Total, serious adverse events | 12 / 173 | 5 / 168 |
Outcome results
Primary
Absence of Gastric and/or Duodenal Ulcer Throughout the Treatment Period
The absence of gastric and/or duodenal ulcer throughout the treatment period
Time frame: each visit up to 24 weeks
Population: Two participants were excluded from these sets because they took no investigational drug or had major protocol deviation. As the result, the numbers of participants for gender baseline were 173 in Esomeprazole 20 mg and 168 in Placebo, respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Esomeprazole 20 mg | Absence of Gastric and/or Duodenal Ulcer Throughout the Treatment Period | 167 Participants |
| Comparater: Placebo | Absence of Gastric and/or Duodenal Ulcer Throughout the Treatment Period | 112 Participants |
Secondary
Absence of Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment
The absence of gastric and/or duodenal ulcer up to 12 weeks after treatment
Time frame: up to 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Esomeprazole 20 mg | Absence of Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment | 168 Participants |
| Comparater: Placebo | Absence of Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment | 119 Participants |
Secondary
Absence of Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment
The absence of gastric and/or duodenal ulcer up to 4 weeks after treatment
Time frame: up to 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental: Esomeprazole 20 mg | Absence of Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment | 172 Participants |
| Comparater: Placebo | Absence of Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment | 133 Participants |