Peptic Ulcer
Conditions
Keywords
histamine-2 receptor antagonist, peptic ulcer, thienopyridine, prevention
Brief summary
Whether H2 receptor antagonist can prevent thienopyridine-related peptic ulcer remains unclear.
Detailed description
The aim of the prospective, randomized study is investigate the efficacy of H2 receptor antagonist in prevention of thienopyridine-related peptic ulcer and gastrointestinal bleeding in patients with an ulcer history. We plan to enroll 236 thienopyridine (clopidogrel or ticlopidine) users with a peptic ulcer history who don't have baseline gastroduodenal ulcers at initial endoscopy . The patients will be randomly assigned to receive either (1) famotidine (40 mg qd) plus thienopyridine used previously or (2) placebo plus thienopyridine treatment alone for 6 months. The ulcer recurrence rate between the treatment gruops will be compared.
Interventions
DRUGhistamine-2 receptor antagonist
famotidine 40 mg qd plus thienopyridine
DRUGPlacebo
placebo plus thienopyridine
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
1. The past history of gastroduodenal ulcer and underwent endoscopy for dyspeptic symptoms. 2. thienopyridine users without baseline gastroduodenal ulcer at initial endoscopy. 3. They are adult patients aged least 20 years of age.
Exclusion criteria
1. They have a history of gastric or duodenal surgery other than oversewing of a perforation. 2. They require long-term treatment with non-steroidal anti-inflammatory drugs. 3. serious disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Healed Peptic Ulcer | 6 months | Follow-up endoscopy was performed at the end of the 6th month |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Histamine-2 Receptor Antagonist Group famotidine 40mg qd for 6 months.
histamine-2 receptor antagonist: famotidine 40 mg qd plus thienopyridine | 114 |
| Placebo Group placebo for 6 months.
Placebo: placebo plus thienopyridine | 114 |
| Total | 228 |
Baseline characteristics
| Characteristic | Histamine-2 Receptor Antagonist Group | Placebo Group | Total |
|---|---|---|---|
| Age, Continuous | 72.7 years STANDARD_DEVIATION 11.9 | 72.9 years STANDARD_DEVIATION 11.1 | 72.8 years STANDARD_DEVIATION 11.5 |
| history of smoking | 14 participants | 10 participants | 24 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 114 Participants | 114 Participants | 228 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 |
| Sex: Female, Male Female | 28 Participants | 36 Participants | 64 Participants |
| Sex: Female, Male Male | 86 Participants | 78 Participants | 164 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 114 | 0 / 114 |
| other Total, other adverse events | 3 / 114 | 2 / 114 |
| serious Total, serious adverse events | 0 / 114 | 0 / 114 |
Outcome results
Primary
Number of Participants With Healed Peptic Ulcer
Follow-up endoscopy was performed at the end of the 6th month
Time frame: 6 months
Population: Intention to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Histamine-2 Receptor Antagonist Group | Number of Participants With Healed Peptic Ulcer | 106 participants |
| Placebo Group | Number of Participants With Healed Peptic Ulcer | 101 participants |