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Research for Prevention and Treatment of NSAIDs Related Gastrointestinal Side Effects

Sponsor
Sun Yat-sen University (Other)
Overall Status
Unknown status
CT.gov ID
NCT01547559
Collaborator
(none)
369
Enrollment
2
Locations
7
Arms
184.5
Patients Per Site

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
369 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Prevention
Official Title:
Evaluation of Preventive and Treatment Effects of Hp Eradication and Teprenone in Patients Taking NSAIDs
Study Start Date :
Jun 1, 2007
Anticipated Primary Completion Date :
Nov 1, 2014

Arms and Interventions

Arm Intervention/Treatment
No Intervention: part1:blank control

NO maintain drugs with Hp negative patients.
Experimental: part1:teprenone 1

maintain treatment with Teprenone for Hp negative patients

Drug: part1:teprenone
Teprenone 50mg tid after meal for Hp negative patients.
Other Names:
  • teprenone treatment

    		•
    Experimental: part1:EAC-T

    eradication of Hp with triple treatment

    Drug: part1:EAC-T
    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
    Other Names:
  • EAC-T treatment

    		•
    Experimental: part1：EA-EMC-T

    eradication of Hp with sequential therapy

    Drug: part1:EA-EMC-T
    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
    Other Names:
  • EA-EMC-T treatment

    		•
    Active Comparator: part1：T-T

    Teprenone as maintain drugs for Hp positive patients

    Drug: part1:teprenone
    Teprenone 50mg tid after meal for Hp positive patients.
    Other Names:
  • T-T treatment

    		•
    Experimental: part2:GGA group

    Geranylgeranylacetone plus diclofenac sodium for patients with rheumatic diseases

    Drug: part2:GGA group
    GGA 50mg three times daily plus diclofenac sodium 75mg once a day for patients with rheumatic diseases.
    Other Names:
  • GGA

    		•
    No Intervention: part2:control group

    diclofenac sodium only for patients with rheumatic diseases

    Outcome Measures

    Primary Outcome Measures

    1. part1:the total proportion of peptic ulcers after treatment [12 weeks]

    2. part2:Capsule endoscopy findings of small-intestinal mucosal injuries after treatment [12 weeks]

    Secondary Outcome Measures

    1. part1:the development of gastroduodenal ulcers [12 weeks]

    2. part1:the healing rate of gastroduodenal ulcers [12 weeks]

    3. part1:the improvement of erosions [12 weeks]

    4. part2：capsule endoscopy (CE) Lewis Score after treatment [12 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 the first Affiliated Hospital of Sun Yat-Sen university Guang zhou Guangdong China 510008
    2 the first Affiliated Hospital of Sun Yat-Sen university Guang zhou Guangdong China 510080

    Sponsors and Collaborators

    • Sun Yat-sen University

    Investigators

    • Study Chair: Minhu Chen, MD PHD, First Affiliated Hospital, Sun Yat-Sen University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xinxin Huang, doctor, Sun Yat-sen University
    ClinicalTrials.gov Identifier:
    NCT01547559
    Other Study ID Numbers:
    • 5010-2007005
    First Posted:
    Mar 8, 2012
    Last Update Posted:
    Oct 21, 2014
    Last Verified:
    Oct 1, 2014
    Additional relevant MeSH terms:
    Drug-Related Side Effects and Adverse Reactions
    Geranylgeranylacetone

    Study Results

    No Results Posted as of Oct 21, 2014