An interventional study of part1:teprenone and part1:EAC-T in Non-steroidal Anti-inflammatory Drug Adverse Reaction, sponsored by Sun Yat-sen University. Status unknown at 2 sites in China. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-10-21.
Sponsored by Sun Yat-sen University · Not applicable, Interventional, and Prevention
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.
437 studies on the registry are indexed under Drug-Related Side Effects and Adverse Reactions; 76 are open to participants now.
This study's enrollment of 369 is above the median of 103 across 255 interventional studies indexed under Drug-Related Side Effects and Adverse Reactions.
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part1:
Inclusion Criteria:
Exclusion Criteria:
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
Exclusion Criteria:
NO maintain drugs with Hp negative patients.
maintain treatment with Teprenone for Hp negative patients
Drug: part1:teprenone
eradication of Hp with triple treatment
Drug: part1:EAC-T
eradication of Hp with sequential therapy
Drug: part1:EA-EMC-T
Teprenone as maintain drugs for Hp positive patients
Drug: part1:teprenone
Geranylgeranylacetone plus diclofenac sodium for patients with rheumatic diseases
Drug: part2:GGA group
diclofenac sodium only for patients with rheumatic diseases
Teprenone 50mg tid after meal for Hp negative patients.
Also known as: teprenone treatment
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
Also known as: EAC-T treatment
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
Also known as: EA-EMC-T treatment
Teprenone 50mg tid after meal for Hp positive patients.
Also known as: T-T treatment
GGA 50mg three times daily plus diclofenac sodium 75mg once a day for patients with rheumatic diseases.
Also known as: GGA
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
This study is status unknown, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.
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Sun Yat-sen University