Clinical trial NCT01547559: Research for Prevention and Treatment of NSAIDs Related Gastrointestinal Side Effects
Official title: Evaluation of Preventive and Treatment Effects of Hp Eradication and Teprenone in Patients Taking NSAIDs
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-steroidal Anti-inflammatory Drug Adverse Reaction
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2012-03-08
Enrollment: 369
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: part1:the total proportion of peptic ulcers after treatment
timeFrame: 12 weeks
measure: part2:Capsule endoscopy findings of small-intestinal mucosal injuries after treatment
timeFrame: 12 weeks
Secondary outcomes:
measure: part1:the development of gastroduodenal ulcers
timeFrame: 12 weeks
measure: part1:the healing rate of gastroduodenal ulcers
timeFrame: 12 weeks
measure: part1:the improvement of erosions
timeFrame: 12 weeks
measure: part2：capsule endoscopy (CE) Lewis Score after treatment
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Guang zhou
country: China
facility: the first Affiliated Hospital of Sun Yat-Sen university
state: Guangdong
city: Guang zhou
country: China
facility: the first Affiliated Hospital of Sun Yat-Sen university
state: Guangdong
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Minhu Chen, MD PHD
role: STUDY_CHAIR
References:
citation: Xiong L, Huang X, Li L, Yang X, Liang L, Zhan Z, Ye Y, Chen M. Geranylgeranylacetone protects against small-intestinal injuries induced by diclofenac in patients with rheumatic diseases: a prospective randomized study. Dig Liver Dis. 2015 Apr;47(4):280-4. doi: 10.1016/j.dld.2015.01.005. Epub 2015 Jan 20.