This trial is active, not recruiting.

Condition non-steroidal anti-inflammatory drug adverse reaction
Treatments part1:teprenone, part1:eac-t, part1:ea-emc-t, part2:gga group
Sponsor Sun Yat-sen University
Start date June 2007
End date November 2014
Trial size 369 participants
Trial identifier NCT01547559, 5010-2007005


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose prevention
(No Intervention)
NO maintain drugs with Hp negative patients.
maintain treatment with Teprenone for Hp negative patients
part1:teprenone teprenone treatment
Teprenone 50mg tid after meal for Hp negative patients.
eradication of Hp with triple treatment
part1:eac-t EAC-T 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
eradication of Hp with sequential therapy
part1:ea-emc-t EA-EMC-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
(Active Comparator)
Teprenone as maintain drugs for Hp positive patients
part1:teprenone T-T treatment
Teprenone 50mg tid after meal for Hp positive patients.
Geranylgeranylacetone plus diclofenac sodium for patients with rheumatic diseases
part2:gga group GGA
GGA 50mg three times daily plus diclofenac sodium 75mg once a day for patients with rheumatic diseases.
(No Intervention)
diclofenac sodium only for patients with rheumatic diseases

Primary Outcomes

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

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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 Exclusion Criteria: 1. Patients were excluded if they had a history of peptic ulcer or gastrointestinal bleeding 2. had serious liver, kidney, heart, or lung disease 3. had suspected small-bowel obstruction 4. had a history of gastrointestinal surgery except for appendectomy 5. had a drug addiction or alcoholism; were pregnant or hoped to become pregnant during the study period 6. were taking anti-secretory drugs such as PPIs or H2 receptor antagonists (H2RA), or other gastric mucosal protective drugs 7. had a lack of consent to the surgery required if the capsule endoscope was retained in the body 8. were judged to be inappropriate for this study by the investigator

Additional Information

Official title Evaluation of Preventive and Treatment Effects of Hp Eradication and Teprenone in Patients Taking NSAIDs
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2014.
Information provided to ClinicalTrials.gov by Sun Yat-sen University.