Gastric Ulcer
Conditions
Keywords
NSAID-associated gastric ulcer
Brief summary
The purpose of this study is to assess the efficacy of esomeprazole 20 mg dosed once daily and ranitidine 150 mg dosed twice daily through 4 weeks of treatment for the healing of gastric ulcers in patients receiving daily non-steroidal anti-inflammatory drug (NSAID)therapy.
Interventions
DRUGEsomeprazole
DRUGRanitidine
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Signed informed consent. * A clinical diagnosis of a chronic condition that requires daily NSAID treatment for at least 2 months. * Daily NSAID dose and type must have been stable for at least 2 weeks prior to the baseline endoscopy;orally;
Exclusion criteria
* History of esophageal, gastric or duodenal surgery, except for simple closure of an ulcer. * History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Subjects Whose Gastric Ulcer(s) (GUs) Was (Were) Healed at Week 4 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily Non-steroidal Anti-inflammatory Drug (NSAID)Therapy. | 4 weeks | Healed was defined as the absence of gastric ulcers. It was calculated as the proportion of subjects whose gastric ulcer(s) healed after 4 weeks treatment. (Ulcers were on S stage, stage 1 = Nonblanchable erythema of intact skin, stage 2 = Partial thickness skin loss involving epidermis, dermis, or both, stage 3 = Full thickness skin loss involving damage to or necrosis of subcutaneous tissue, stage 4 = Full thickness skin loss with extensive destruction, tissue necrosis, or damage to muscle, bone, or supporting structures or absent). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Subjects Whose Gastric Ulcer(s) Was (Were) Healed at Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy. | 8 weeks | Healed was defined as the absence of gastric ulcers (Ulcers were on S stage or absent). It was calculated as the proportion of subjects whose gastric ulcer(s) healed after 8 weeks treatment. |
| The Resolution of Heartburn Symptoms at Week 4 and Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy. | week 4 and week 8 | Resolution rate of investigator-assessed GI symptoms, including heartburn, acid regurgitation, nausea, abdominal fullness and sleep disorder. It was calculated as the percentage of subjects whose heartburn symptoms were resolved at Week 8. |
| Percentage of Participants With the Occurance of Any Adverse Event. | 8 weeks | Safety evaluation including vital signs, physical examination, ECG, adverse events and clinical laboratory evaluations during 8 weeks treatment. |
| The Percentage of Participants Whose Duodenal Ulcer(s) (DUs) Was (Were) Healed at Week 4 and Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy. | 4 and 8 week | Healed was defined as the absence of ulcers (Ulcers were on S stage or absent). It was calculated as the proportion of subjects whose duodenal ulcer healed after 4 and 8 weeks treatment. |
| The Percentage of Participants Whose GU(s) and DU(s) in Combination Were Healed at Week 4 and Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy | 4 & 8 weeks | Healed was defined as the absence of ulcers (Ulcers were on S stage or absent). It was calculated as the proportion of subjects whose gastric and duodenal ulcer healed after 4 and 8 weeks treatment. |
Countries
China, Hong Kong
Participant flow
Recruitment details
Total 219 patients from 18 centers in China who had been receiving a stable daily dose of 1 or more NSAIDs for at least 2 weeks and who had an NSAID-associated GU verified by EGD at baseline were randomized. The first patient was enrolled on 31 Mar 2006, the last patient was completed on 17 Nov 2008.
Pre-assignment details
Total 397 patients from 24 centers in China were enrolled. 178 patients were not randomised due to unwillingness to continue the study or development of any exclusion criteria, etc. Total 219 patients were randomised, 217 patients were included in ITT population.
Participants by arm
| Arm | Count |
|---|---|
| Esomeprazole Esomeprazole 20 mg tablet qd oral administration | 106 |
| Ranitidine ranitidine 150 mg capsule bid oral administration | 111 |
| Total | 217 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 5 |
| Overall Study | Development of any exclusion criteria | 4 | 2 |
| Overall Study | Lost to Follow-up | 1 | 4 |
| Overall Study | Physician Decision | 1 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 6 |
Baseline characteristics
| Characteristic | Esomeprazole | Ranitidine | Total |
|---|---|---|---|
| Age Continuous | 49.7 year STANDARD_DEVIATION 11.01 | 50.9 year STANDARD_DEVIATION 10.2 | 50.3 year STANDARD_DEVIATION 10.6 |
| Sex: Female, Male Female | 51 Participants | 53 Participants | 104 Participants |
| Sex: Female, Male Male | 55 Participants | 58 Participants | 113 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 13 / — | 16 / — |
| serious Total, serious adverse events | 2 / 107 | 2 / 110 |
Outcome results
Primary
The Percentage of Subjects Whose Gastric Ulcer(s) (GUs) Was (Were) Healed at Week 4 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily Non-steroidal Anti-inflammatory Drug (NSAID)Therapy.
Healed was defined as the absence of gastric ulcers. It was calculated as the proportion of subjects whose gastric ulcer(s) healed after 4 weeks treatment. (Ulcers were on S stage, stage 1 = Nonblanchable erythema of intact skin, stage 2 = Partial thickness skin loss involving epidermis, dermis, or both, stage 3 = Full thickness skin loss involving damage to or necrosis of subcutaneous tissue, stage 4 = Full thickness skin loss with extensive destruction, tissue necrosis, or damage to muscle, bone, or supporting structures or absent).
Time frame: 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Esomeprazole | The Percentage of Subjects Whose Gastric Ulcer(s) (GUs) Was (Were) Healed at Week 4 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily Non-steroidal Anti-inflammatory Drug (NSAID)Therapy. | 59.4 Percentage of participants |
| Ranitidine | The Percentage of Subjects Whose Gastric Ulcer(s) (GUs) Was (Were) Healed at Week 4 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily Non-steroidal Anti-inflammatory Drug (NSAID)Therapy. | 59.5 Percentage of participants |
Secondary
Percentage of Participants With the Occurance of Any Adverse Event.
Safety evaluation including vital signs, physical examination, ECG, adverse events and clinical laboratory evaluations during 8 weeks treatment.
Time frame: 8 weeks
Population: Patients included in safety population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Esomeprazole | Percentage of Participants With the Occurance of Any Adverse Event. | 16.8 Percentage of participants |
| Ranitidine | Percentage of Participants With the Occurance of Any Adverse Event. | 22.7 Percentage of participants |
Secondary
The Percentage of Participants Whose Duodenal Ulcer(s) (DUs) Was (Were) Healed at Week 4 and Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy.
Healed was defined as the absence of ulcers (Ulcers were on S stage or absent). It was calculated as the proportion of subjects whose duodenal ulcer healed after 4 and 8 weeks treatment.
Time frame: 4 and 8 week
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Esomeprazole | The Percentage of Participants Whose Duodenal Ulcer(s) (DUs) Was (Were) Healed at Week 4 and Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy. | 93.3 Percentage of participants |
| Ranitidine | The Percentage of Participants Whose Duodenal Ulcer(s) (DUs) Was (Were) Healed at Week 4 and Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy. | 81.8 Percentage of participants |
Secondary
The Percentage of Participants Whose GU(s) and DU(s) in Combination Were Healed at Week 4 and Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy
Healed was defined as the absence of ulcers (Ulcers were on S stage or absent). It was calculated as the proportion of subjects whose gastric and duodenal ulcer healed after 4 and 8 weeks treatment.
Time frame: 4 & 8 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Esomeprazole | The Percentage of Participants Whose GU(s) and DU(s) in Combination Were Healed at Week 4 and Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy | 80.2 Percentage of participants |
| Ranitidine | The Percentage of Participants Whose GU(s) and DU(s) in Combination Were Healed at Week 4 and Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy | 69.4 Percentage of participants |
Secondary
The Percentage of Subjects Whose Gastric Ulcer(s) Was (Were) Healed at Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy.
Healed was defined as the absence of gastric ulcers (Ulcers were on S stage or absent). It was calculated as the proportion of subjects whose gastric ulcer(s) healed after 8 weeks treatment.
Time frame: 8 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Esomeprazole | The Percentage of Subjects Whose Gastric Ulcer(s) Was (Were) Healed at Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy. | 81.1 Percentage of participants |
| Ranitidine | The Percentage of Subjects Whose Gastric Ulcer(s) Was (Were) Healed at Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy. | 73.9 Percentage of participants |
Secondary
The Resolution of Heartburn Symptoms at Week 4 and Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy.
Resolution rate of investigator-assessed GI symptoms, including heartburn, acid regurgitation, nausea, abdominal fullness and sleep disorder. It was calculated as the percentage of subjects whose heartburn symptoms were resolved at Week 8.
Time frame: week 4 and week 8
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Esomeprazole | The Resolution of Heartburn Symptoms at Week 4 and Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy. | 100 Percentage of participants |
| Ranitidine | The Resolution of Heartburn Symptoms at Week 4 and Week 8 After Treatment With Esomeprazole 20 mg qd and Ranitidine 150 mg Bid in Patients Receiving Daily NSAID Therapy. | 97.7 Percentage of participants |