Research for Prevention and Treatment of NSAIDs Related Gastrointestinal Side Effects

Not Applicable

• Conditions: Non-steroidal Anti-inflammatory Drug Adverse Reaction

• Registration Number: NCT01547559
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2012-03-07
• Study First Submitted QC: 2012-03-07
• Study First Posted: 2012-03-08
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-20
• Last Update Posted: 2014-10-21
• Primary Completion: 2014-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 369

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

the first Affiliated Hospital of Sun Yat-Sen university; 🇨🇳 Guang zhou, Guangdong, China