Stomach Ulcer
Conditions
Brief summary
To examine the efficacy of continued administration of rebamipide following bacteria eradication therapy in patients with H. pylori-positive active gastric ulcer in a placebo-controlled, double-blind study
Interventions
DRUGRebamipide
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients aged 20 years or older at time of consent 2. H. pylori-positive patients meeting both of the following criteria:• Assessed as H. pylori-positive by rapid urease test and/or 13C-urea breath test at pre-study examination, • Assessed as H. pylori-antibody-positive by urine-based test after obtaining informed consent 3. Patients endoscopically diagnosed with gastric ulcer meeting the following criteria:• Active (A1- or A2-stage by Sakita/Miwa classification）, • Solitary, • Longitudinal diameter: -\>5 mm 4. Patients who have not received proton pump inhibitors (PPIs), antibacterial agents, or antiprotozoal agents within 1 week prior to endoscopy
Exclusion criteria
1. Patients who have previously received H. pylori eradication therapy 2. Patients with acute gastric ulcer 3. Patients with linear ulcer 4. Patients with complication of duodenal ulcer (excluding cicatrix) 5. Patients who have undergone upper-GI tract or vagal nerve resection 6. Patients who are unsuitable for pharmacotherapy, e.g., with perforation or pyloric stenosis 7. Patients with gastric ulcer considered likely to induce massive hemorrhage (e.g., with obviously exposed blood vessels at lesion sites) 8. Patients with a history of amoxicillin shock 9. Patients with infectious mononucleosis 10. Patients with severe renal disorders 11. Patients with a history of hypersensitivity to penicillins, clarithromycin, lansoprazole, or rebamipide 12. Patients who have been treated with drugs contraindicated to clarithromycin, such as terfenadine, cisapride, and pimozide 13. Patients who are pregnant, possibly pregnant, lactating, or who desire to become pregnant during the study 14. Patients who are otherwise judged inappropriate for inclusion in the study by the investigator or subinvestigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastric Ulcer Healing Rate (Number of Subjects Whose Gastric Ulcer Was Healed/Number of Subjects Evaluated x 100) at Week 8 | Week 8 | The percentage of subjects in the analysis set in whom endoscopic assessment of gastric ulcer stage (Sakita-Miwa Classification: A1, A2, H1, H2, S1, or S2) at 8 weeks after trial treatment (H. pylori eradication therapy + IMP) was judged as healed (S1 or S2) was calculated and evaluated by group. |
Countries
Japan
Participant flow
Pre-assignment details
Following the eradication therapy period, 154 subjects in the rebamipide group and 147 subjects in the placebo group, excluding withdrawals during the eradication therapy period, received the investigational medicinal product (IMP) (rebamipide or placebo) for the treatment of gastric ulcer.
Participants by arm
| Arm | Count |
|---|---|
| Rebamipide Following 1 week of H. pylori eradication therapy, a rebamipide 100 mg tablet was administered orally three times a day for 7 weeks. | 154 |
| Placebo Following 1 week of H. pylori eradication therapy, a placebo tablet was administered orally three times a day for 7 weeks. | 147 |
| Total | 301 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 5 | 5 |
| Overall Study | Lack of Efficacy | 11 | 8 |
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Rebamipide | Placebo | Total |
|---|---|---|---|
| Age, Customized 20-39 years | 21 Participants | 19 Participants | 40 Participants |
| Age, Customized 40-59 years | 99 Participants | 84 Participants | 183 Participants |
| Age, Customized >=60 years | 34 Participants | 44 Participants | 78 Participants |
| Region of Enrollment Japan | 154 Participants | 147 Participants | 301 Participants |
| Sex: Female, Male Female | 52 Participants | 48 Participants | 100 Participants |
| Sex: Female, Male Male | 102 Participants | 99 Participants | 201 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 154 | 0 / 147 |
| other Total, other adverse events | 85 / 154 | 75 / 147 |
| serious Total, serious adverse events | 2 / 154 | 1 / 147 |
Outcome results
Primary
Gastric Ulcer Healing Rate (Number of Subjects Whose Gastric Ulcer Was Healed/Number of Subjects Evaluated x 100) at Week 8
The percentage of subjects in the analysis set in whom endoscopic assessment of gastric ulcer stage (Sakita-Miwa Classification: A1, A2, H1, H2, S1, or S2) at 8 weeks after trial treatment (H. pylori eradication therapy + IMP) was judged as healed (S1 or S2) was calculated and evaluated by group.
Time frame: Week 8
Population: Full Efficacy Analysis Set: Subjects who received H. pylori eradication therapy as specified and at least one dose of the IMP.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rebamipide | Gastric Ulcer Healing Rate (Number of Subjects Whose Gastric Ulcer Was Healed/Number of Subjects Evaluated x 100) at Week 8 | 70.13 percentage of participants |
| Placebo | Gastric Ulcer Healing Rate (Number of Subjects Whose Gastric Ulcer Was Healed/Number of Subjects Evaluated x 100) at Week 8 | 60.54 percentage of participants |