Peptic Ulcer
Conditions
Keywords
histamine-2 receptor antagonist, proton pump inhibitor, thienopyridine, clopidogrel, prevention
Brief summary
Whether pantoprazole versus famotidine for the prevention of recurrent peptic ulcers in thienopyridine users remains unclear.
Detailed description
The aims of the randomized double-blind comparison study are to compare the efficacy of Proton Pump Inhibitor and H2 receptor antagonist for the prevention of recurrent peptic ulcers in thienopyridine users. We plan to enroll 334 thienopyridine (clopidogrel or ticlopidine) users without baseline gastroduodenal ulcer at initial endoscopy. The patients will be randomly assigned to receive either (1) pantoprazole (40 mg qd) or (2) famotidine (40 mg qd) for 6 months.The ulcer recurrence rate between the treatment groups will be compared.
Interventions
DRUGhistamine-2 receptor antagonist group
famotidine tab 40 mg qd for 6 months.
DRUGproton pump inhibitor group
pantoprazole tab 40 mg qd for 6 months.
Sponsors
Kaohsiung Veterans General Hospital.
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 90 Years
Healthy volunteers
No
Inclusion criteria
* Recent endoscopic examination (within 2 months) reveals normal appearance or erythematous patches only (without subepithelial hemorrhages, erosions or ulcers). * Peptic ulcers (a mucosal break ³ 5 mm in diameter) have been documented by a previous endoscopic examination. * Subjects have received thienopyridine therapy for at least two weeks. * Requiring long-term anti-platelet therapy for ischemic cardiovascular diseases.
Exclusion criteria
* A history of gastric or duodenal surgery other than oversewing of a perforation. * Subjects who are allergic to the study drugs. * Requiring long-term treatment with non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, aspirin, or anticoagulant agents. * Pregnancy. * Subjects who have active cancer, acute serious medical illness or terminal illness. * Subjects who have gastroesophageal reflux disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Ulcer Recurrence | six month | Follow-up endoscopy was performed at the end of the 6th month |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Proton Pump Inhibitor Group Pantoprazole Tab 40mg qd for 6 monthrs.
proton pump inhibitor group: pantoprazole tab 40 mg qd for 6 months. | 50 |
| Histamine-2 Receptor Antagonist Group famotidine Tab 40 mg qd for 6 months.
histamine-2 receptor antagonist group: famotidine tab 40 mg qd for 6 months. | 51 |
| Total | 101 |
Baseline characteristics
| Characteristic | Proton Pump Inhibitor Group | Histamine-2 Receptor Antagonist Group | Total |
|---|---|---|---|
| Age, Continuous | 73.1 years STANDARD_DEVIATION 11.1 | 71.8 years STANDARD_DEVIATION 10.9 | 72.4 years STANDARD_DEVIATION 11 |
| history of smoking | 3 participants | 4 participants | 7 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 50 Participants | 51 Participants | 101 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Taiwan | 50 participants | 51 participants | 101 participants |
| Sex: Female, Male Female | 13 Participants | 10 Participants | 23 Participants |
| Sex: Female, Male Male | 37 Participants | 41 Participants | 78 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 51 |
| other Total, other adverse events | 1 / 50 | 1 / 51 |
| serious Total, serious adverse events | 0 / 50 | 0 / 51 |
Outcome results
Primary
Number of Participants With Ulcer Recurrence
Follow-up endoscopy was performed at the end of the 6th month
Time frame: six month
Population: Intention to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Proton Pump Inhibitor Group | Number of Participants With Ulcer Recurrence | 1 participants |
| Histamine-2 Receptor Antagonist Group | Number of Participants With Ulcer Recurrence | 7 participants |