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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
369
Teprenone 50mg tid after meal for Hp negative patients.
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
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
the first Affiliated Hospital of Sun Yat-Sen university
Guangzhou, Guangdong, China
the first Affiliated Hospital of Sun Yat-Sen university
Guangzhou, Guangdong, China
part1:the total proportion of peptic ulcers after treatment
Time frame: 12 weeks
part2:Capsule endoscopy findings of small-intestinal mucosal injuries after treatment
Time frame: 12 weeks
part1:the development of gastroduodenal ulcers
Time frame: 12 weeks
part1:the healing rate of gastroduodenal ulcers
Time frame: 12 weeks
part1:the improvement of erosions
Time frame: 12 weeks
part2:capsule endoscopy (CE) Lewis Score after treatment
Time frame: 12 weeks
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Teprenone 50mg tid after meal for Hp positive patients.
GGA 50mg three times daily plus diclofenac sodium 75mg once a day for patients with rheumatic diseases.