Non-steroidal Anti-inflammatory Drug Adverse Reaction
Conditions
Brief summary
We aim to evaluate the protective effects of eradication of HP and continue using Geranylgeranylacetone (GGA) on NSAIDs related gastroenterological lesions. We further aim to explore the effect of GGA on small-intestinal mucosal injuries induced by diclofenac sodium in patients with rheumatic diseases who didn't take NSAIDs in the preceding 6 months.
Detailed description
NSAIDs are mainly used drugs in rheumatic disease and cardiologic disease. However the gastroenterological lesions prevent patients get benefits from continuing taking NSAIDs. HP is another important factor that increase gastroenterological lesions. Both HP and NSAIDs increase risk of peptic ulcers, however, no exact relation between these two factors has been found. It is important to evaluate the protective effects of eradication of HP in NSAIDs-taking patients. In many countries ,PPI is recommended as maintain treatment in NSAIDs-taking patients to prevent gastroenterological lesions. A multicenter, open-label, randomized, parallel-group study is needed to prove the effects of Teprenone as a replacer of PPI in maintain treatment.On the other hand, Small-intestinal mucosal injuries induced by non-steroidal anti-inflammatory drugs (NSAIDs) are common. However, there are still no effective and reliable interventions established. Geranylgeranylacetone (GGA) is a mucosal protective agent, so we develop an additional trail to clarify the discrepancies of GGA effects on NSAIDs-induced small-intestinal mucosal injuries.
Interventions
DRUGpart1:teprenone
Teprenone 50mg tid after meal for Hp negative patients.
DRUGpart1:EAC-T
esomeprazole 20 mg, amoxicillin 1 g, and clarithromycin 500 mg, each twice daily followed by gastric mucosal protective therapy with teprenone 50mg three times daily for 11 weeks
DRUGpart1:EA-EMC-T
esomeprazole 20 mg plus amoxicillin 1 g, twice daily for 5 days, then esomeprazole 20 mg with clarithromycin 500 mg and metronidazole 500 mg, twice daily for another 5 consecutive days) followed by teprenone 50mg three times daily until 12 weeks
DRUGpart2:GGA group
GGA 50mg three times daily plus diclofenac sodium 75mg once a day for patients with rheumatic diseases.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
part1: Inclusion Criteria: 1. informed consents be given before treatment 2. NSAIDs taking patients 3. not taking PPI or other digestive drugs during previous 1 months 4. age ranging from 18～80 years old
Exclusion criteria
1. having any severe acute or chronic complications 2. renal dysfunction, blood creatinine≥150µmol/L 3. blood aminotransferase level rising up(more than 2 times of the normal level) 4. any severe cardiac disease including congestive cardiac failure, unstable angina and myocardial infarct in 12 months 5. serious hypertension (systolic pressure≥180mmHg and/ or diastolic pressure≥110mmHg) 6. chronic or acute pancreatic disease 7. severe systematic diseases or malignant tumor 8. allergic to the drugs using in the trial 9. any factors interfering the result 10. female patients incline to be pregnant 11. being treated with drugs influencing gastroenterological conditions. 12. poor compliance part2: Inclusion Criteria: 1.18 to 65 years of age 2.patients with rheumatic diseases such as ankylosing spondylitis , rheumatoid arthritis and undifferentiated arthritis 3.planning to take diclofenac sodium for at least 12 weeks 4.having freely been given their fully informed consent based on their full understanding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| part1:the total proportion of peptic ulcers after treatment | 12 weeks |
| part2:Capsule endoscopy findings of small-intestinal mucosal injuries after treatment | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| part1:the development of gastroduodenal ulcers | 12 weeks |
| part1:the healing rate of gastroduodenal ulcers | 12 weeks |
| part1:the improvement of erosions | 12 weeks |
| part2：capsule endoscopy (CE) Lewis Score after treatment | 12 weeks |
Countries
China
Outcome results
None listed