Gastric Ulcer, Duodenal Ulcer, Rheumatoid Arthritis, Osteoarthritis, Lumbago
Conditions
Keywords
gastrointestinal, GI, NSAID, Japan, Japanese, Gastric ulcer, duodenal ulcer
Brief summary
The purpose of this study is to assess the Safety and tolerability of D961H (Esomeprazole) 20 mg once daily for up to 52 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID) therapy by evaluating AE, clinical laboratory value and vital signs.
Interventions
Esomeprazole 20 mg once daily
Sponsors
AstraZeneca
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
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 |
|---|---|
| Number of Participants Without Gastric and/or Duodenal Ulcer Throughout the Treatment Period | up to 52 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants Without Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment | up to 4 weeks after treatment |
| Number of Participants Without Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment | up to 12 weeks after treatment |
| Number of Participants Without Gastric and/or Duodenal Ulcer up to 24 Weeks After Treatment | up to 24 weeks after treatment |
Countries
Japan
Participant flow
Recruitment details
First participant enrolled 2 Oct 07. Last completed 8 Sept 09. 395 enrolled, 130 registered in study. All registered were included in Full Analysis set and safety analysis set. FAS used for summaries of baseline characteristics and efficacy, safety analysis set for summaries of safety variables.
Pre-assignment details
Out of 395 enrolled participants, 130 participants were registered and 265 participants were not registered. The major reasons of no registration were 'Incorrect enrollment' (247 participants) and 'Voluntary discontinuation by participant' (18 participants).
Participants by arm
| Arm | Count |
|---|---|
| Esomeprazole 20mg Esomeprazole 20 mg once daily oral | 130 |
| Total | 130 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 6 |
| Overall Study | No intention to attend regularly | 1 |
| Overall Study | Protocol Violation | 2 |
| Overall Study | Recurrence of ulcer | 5 |
| Overall Study | usage of prohibited treatment | 1 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Esomeprazole 20mg |
|---|---|
| Age, Customized 65 - 74 years | 43 Participants |
| Age, Customized < 65 years | 63 Participants |
| Age, Customized >= 75 years | 24 Participants |
| Sex/Gender, Customized Female | 95 Participants |
| Sex/Gender, Customized Male | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 123 / 130 |
| serious Total, serious adverse events | 14 / 130 |
Outcome results
Primary
Number of Participants Without Gastric and/or Duodenal Ulcer Throughout the Treatment Period
Time frame: up to 52 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Esomeprazole 20mg | Number of Participants Without Gastric and/or Duodenal Ulcer Throughout the Treatment Period | 125 Participants |
Secondary
Number of Participants Without Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment
Time frame: up to 12 weeks after treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Esomeprazole 20mg | Number of Participants Without Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment | 127 participants |
Secondary
Number of Participants Without Gastric and/or Duodenal Ulcer up to 24 Weeks After Treatment
Time frame: up to 24 weeks after treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Esomeprazole 20mg | Number of Participants Without Gastric and/or Duodenal Ulcer up to 24 Weeks After Treatment | 126 participants |
Secondary
Number of Participants Without Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment
Time frame: up to 4 weeks after treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Esomeprazole 20mg | Number of Participants Without Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment | 130 Participants |