Research for Prevention and Treatment of NSAIDs Related Gastrointestinal Side Effects

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Diclofenac; Geranylgeranylacetone

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

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