Back to resultsResearch for Prevention and Treatment of NSAIDs Related Gastrointestinal Side Effects
Primary Purpose
Non-steroidal Anti-inflammatory Drug Adverse Reaction
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
part1:teprenone
part1:EAC-T
part1:EA-EMC-T
part1:teprenone
part2:GGA group
Sponsored by
About this trial
This is an interventional prevention trial for Non-steroidal Anti-inflammatory Drug Adverse Reaction
Eligibility Criteria
part1:
Inclusion Criteria:
- informed consents be given before treatment
- NSAIDs taking patients
- not taking PPI or other digestive drugs during previous 1 months
- age ranging from 18～80 years old
Exclusion Criteria:
- having any severe acute or chronic complications
- renal dysfunction, blood creatinine≥150µmol/L
- blood aminotransferase level rising up(more than 2 times of the normal level)
- any severe cardiac disease including congestive cardiac failure, unstable angina and myocardial infarct in 12 months
- serious hypertension (systolic pressure≥180mmHg and/ or diastolic pressure≥110mmHg)
- chronic or acute pancreatic disease
- severe systematic diseases or malignant tumor
- allergic to the drugs using in the trial
- any factors interfering the result
- female patients incline to be pregnant
- being treated with drugs influencing gastroenterological conditions.
- 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:
- Patients were excluded if they had a history of peptic ulcer or gastrointestinal bleeding
- had serious liver, kidney, heart, or lung disease
- had suspected small-bowel obstruction
- had a history of gastrointestinal surgery except for appendectomy
- had a drug addiction or alcoholism; were pregnant or hoped to become pregnant during the study period
- were taking anti-secretory drugs such as PPIs or H2 receptor antagonists (H2RA), or other gastric mucosal protective drugs
- had a lack of consent to the surgery required if the capsule endoscope was retained in the body
- were judged to be inappropriate for this study by the investigator
Sites / Locations
- the first Affiliated Hospital of Sun Yat-Sen university
- the first Affiliated Hospital of Sun Yat-Sen university
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm Type
No Intervention
Experimental
Experimental
Experimental
Active Comparator
Experimental
No Intervention
Arm Label
part1:blank control
part1:teprenone 1
part1:EAC-T
part1：EA-EMC-T
part1：T-T
part2:GGA group
part2:control group
Arm Description
NO maintain drugs with Hp negative patients.
maintain treatment with Teprenone for Hp negative patients
eradication of Hp with triple treatment
eradication of Hp with sequential therapy
Teprenone as maintain drugs for Hp positive patients
Geranylgeranylacetone plus diclofenac sodium for patients with rheumatic diseases
diclofenac sodium only for patients with rheumatic diseases
Outcomes
Primary Outcome Measures
part1:the total proportion of peptic ulcers after treatment
part2:Capsule endoscopy findings of small-intestinal mucosal injuries after treatment
Secondary Outcome Measures
part1:the development of gastroduodenal ulcers
part1:the healing rate of gastroduodenal ulcers
part1:the improvement of erosions
part2：capsule endoscopy (CE) Lewis Score after treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01547559
Brief Title
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
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2007 (undefined)
Primary Completion Date
November 2014 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-steroidal Anti-inflammatory Drug Adverse Reaction
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
369 (Actual)
8. Arms, Groups, and Interventions
Arm Title
part1:blank control
Arm Type
No Intervention
Arm Description
NO maintain drugs with Hp negative patients.
Arm Title
part1:teprenone 1
Arm Type
Experimental
Arm Description
maintain treatment with Teprenone for Hp negative patients
Arm Title
part1:EAC-T
Arm Type
Experimental
Arm Description
eradication of Hp with triple treatment
Arm Title
part1：EA-EMC-T
Arm Type
Experimental
Arm Description
eradication of Hp with sequential therapy
Arm Title
part1：T-T
Arm Type
Active Comparator
Arm Description
Teprenone as maintain drugs for Hp positive patients
Arm Title
part2:GGA group
Arm Type
Experimental
Arm Description
Geranylgeranylacetone plus diclofenac sodium for patients with rheumatic diseases
Arm Title
part2:control group
Arm Type
No Intervention
Arm Description
diclofenac sodium only for patients with rheumatic diseases
Intervention Type
Drug
Intervention Name(s)
part1:teprenone
Other Intervention Name(s)
teprenone treatment
Intervention Description
Teprenone 50mg tid after meal for Hp negative patients.
Intervention Type
Drug
Intervention Name(s)
part1:EAC-T
Other Intervention Name(s)
EAC-T treatment
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
part1:EA-EMC-T
Other Intervention Name(s)
EA-EMC-T treatment
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
part1:teprenone
Other Intervention Name(s)
T-T treatment
Intervention Description
Teprenone 50mg tid after meal for Hp positive patients.
Intervention Type
Drug
Intervention Name(s)
part2:GGA group
Other Intervention Name(s)
GGA
Intervention Description
GGA 50mg three times daily plus diclofenac sodium 75mg once a day for patients with rheumatic diseases.
Primary Outcome Measure Information:
Title
part1:the total proportion of peptic ulcers after treatment
Time Frame
12 weeks
Title
part2:Capsule endoscopy findings of small-intestinal mucosal injuries after treatment
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
part1:the development of gastroduodenal ulcers
Time Frame
12 weeks
Title
part1:the healing rate of gastroduodenal ulcers
Time Frame
12 weeks
Title
part1:the improvement of erosions
Time Frame
12 weeks
Title
part2：capsule endoscopy (CE) Lewis Score after treatment
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
part1:
Inclusion Criteria:
informed consents be given before treatment
NSAIDs taking patients
not taking PPI or other digestive drugs during previous 1 months
age ranging from 18～80 years old
Exclusion Criteria:
having any severe acute or chronic complications
renal dysfunction, blood creatinine≥150µmol/L
blood aminotransferase level rising up(more than 2 times of the normal level)
any severe cardiac disease including congestive cardiac failure, unstable angina and myocardial infarct in 12 months
serious hypertension (systolic pressure≥180mmHg and/ or diastolic pressure≥110mmHg)
chronic or acute pancreatic disease
severe systematic diseases or malignant tumor
allergic to the drugs using in the trial
any factors interfering the result
female patients incline to be pregnant
being treated with drugs influencing gastroenterological conditions.
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:
Patients were excluded if they had a history of peptic ulcer or gastrointestinal bleeding
had serious liver, kidney, heart, or lung disease
had suspected small-bowel obstruction
had a history of gastrointestinal surgery except for appendectomy
had a drug addiction or alcoholism; were pregnant or hoped to become pregnant during the study period
were taking anti-secretory drugs such as PPIs or H2 receptor antagonists (H2RA), or other gastric mucosal protective drugs
had a lack of consent to the surgery required if the capsule endoscope was retained in the body
were judged to be inappropriate for this study by the investigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Minhu Chen, MD PHD
Organizational Affiliation
First Affiliated Hospital, Sun Yat-Sen University
Official's Role
Study Chair
Facility Information:
Facility Name
the first Affiliated Hospital of Sun Yat-Sen university
City
Guang zhou
State/Province
Guangdong
ZIP/Postal Code
510008
Country
China
Facility Name
the first Affiliated Hospital of Sun Yat-Sen university
City
Guang zhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
25660821
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.
Results Reference
derived
Learn more about this trial
Research for Prevention and Treatment of NSAIDs Related Gastrointestinal Side Effects
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