Non-steroidal Anti-inflammatory Drug Adverse ReactionNCT01547559
Research for Prevention and Treatment of NSAIDs Related Gastrointestinal Side Effects
A study testing part1:teprenone, part1:EAC-T and part1:EA-EMC-T in people with Non-steroidal Anti-inflammatory Drug Adverse Reaction, run by Sun Yat-sen University at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-steroidal Anti-inflammatory Drug Adverse Reaction
- What is being tested?
- part1:teprenone, part1:EAC-T and part1:EA-EMC-T
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 369 participants
- Where
- 2 sitesChina
- Study dates
- Jun 2007to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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:
- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites
the first Affiliated Hospital of Sun Yat-Sen university
Guangzhou, Guangdong, 510008
the first Affiliated Hospital of Sun Yat-Sen university
Guangzhou, Guangdong, 510080
About this study
Official title: Evaluation of Preventive and Treatment Effects of Hp Eradication and Teprenone in Patients Taking NSAIDs
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.
Read the 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.
- Being tested
- part1:teprenone, part1:EAC-T, part1:EA-EMC-T, part2:GGA group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
part1:teprenoneDrug
Also called teprenone treatment
Teprenone 50mg tid after meal for Hp negative patients.
part1:EAC-TDrug
Also called EAC-T treatment
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
part1:EA-EMC-TDrug
Also called EA-EMC-T treatment
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
part1:teprenoneDrug
Also called T-T treatment
Teprenone 50mg tid after meal for Hp positive patients.
part2:GGA groupDrug
Also called GGA
GGA 50mg three times daily plus diclofenac sodium 75mg once a day for patients with rheumatic diseases.
| Study group | Role | What they receive |
|---|---|---|
| part1:blank control | No intervention | NO maintain drugs with Hp negative patients. |
| part1:teprenone 1 | Experimental | maintain treatment with Teprenone for Hp negative patients Receives: Drug: part1:teprenone |
| part1:EAC-T | Experimental | eradication of Hp with triple treatment Receives: Drug: part1:EAC-T |
| part1：EA-EMC-T | Experimental | eradication of Hp with sequential therapy Receives: Drug: part1:EA-EMC-T |
| part1：T-T | Active comparator | Teprenone as maintain drugs for Hp positive patients Receives: Drug: part1:teprenone |
| part2:GGA group | Experimental | Geranylgeranylacetone plus diclofenac sodium for patients with rheumatic diseases Receives: Drug: part2:GGA group |
| part2:control group | No intervention | diclofenac sodium only for patients with rheumatic diseases |
What is being measured
The primary outcome is the main question the study is designed to answer.
part1:the total proportion of peptic ulcers after treatment
Measured: 12 weeks
part2:Capsule endoscopy findings of small-intestinal mucosal injuries after treatment
Measured: 12 weeks
Secondary outcomes (4)
part1:the development of gastroduodenal ulcers
Measured: 12 weeks
part1:the healing rate of gastroduodenal ulcers
Measured: 12 weeks
part1:the improvement of erosions
Measured: 12 weeks
part2：capsule endoscopy (CE) Lewis Score after treatment
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2012 (estimated)
- Study startJun 2007
- Primary completionNov 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-steroidal Anti-inflammatory Drug Adverse ReactionStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 369 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xinxin Huang, Sun Yat-sen University
- Investigators
- Minhu Chen, MD PHD, Study chair, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01547559
- Sponsor's protocol ID
- 5010-2007005
- Status last verified
- Oct 2014
- First submitted
- 7 Mar 2012
- Last updated
- 21 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25660821
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Preventive and Treatment Effects of Hp Eradication and Teprenone in Patients Taking NSAIDs
- ClinicalTrials.gov ID
- NCT01547559
- Acronym / sponsor ID
- 5010-2007005
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 369 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Nov 2014 (estimated)
- First posted
- 8 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| part1:blank control | No intervention | –NO maintain drugs with Hp negative patients. |
| part1:teprenone 1 | Experimental | Drug: part1:teprenonemaintain treatment with Teprenone for Hp negative patients |
| part1:EAC-T | Experimental | Drug: part1:EAC-Teradication of Hp with triple treatment |
| part1：EA-EMC-T | Experimental | Drug: part1:EA-EMC-Teradication of Hp with sequential therapy |
| part1：T-T | Active comparator | Drug: part1:teprenoneTeprenone as maintain drugs for Hp positive patients |
| part2:GGA group | Experimental | Drug: part2:GGA groupGeranylgeranylacetone plus diclofenac sodium for patients with rheumatic diseases |
| part2:control group | No intervention | –diclofenac sodium only for patients with rheumatic diseases |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- 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
Key exclusion criteria (20 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| part1:teprenoneAlso: teprenone treatmentTeprenone 50mg tid after meal for Hp negative patients. | Drug | part1:teprenone 1 |
| part1:EAC-TAlso: EAC-T treatmentesomeprazole 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 | Drug | part1:EAC-T |
| part1:EA-EMC-TAlso: EA-EMC-T treatmentesomeprazole 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 | Drug | part1：EA-EMC-T |
| part1:teprenoneAlso: T-T treatmentTeprenone 50mg tid after meal for Hp positive patients. | Drug | part1：T-T |
| part2:GGA groupAlso: GGAGGA 50mg three times daily plus diclofenac sodium 75mg once a day for patients with rheumatic diseases. | Drug | part2:GGA group |
Primary outcome
part1:the total proportion of peptic ulcers after treatment
Time frame: 12 weeks
part2:Capsule endoscopy findings of small-intestinal mucosal injuries after treatment
Time frame: 12 weeks
4 secondary outcomes
part1:the development of gastroduodenal ulcers
Time frame: 12 weeks
part1:the healing rate of gastroduodenal ulcers
Time frame: 12 weeks
part1:the improvement of erosions
Time frame: 12 weeks
part2：capsule endoscopy (CE) Lewis Score after treatment
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2014.
- Derived from this study: PubMed 25660821Xiong 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Minhu Chen, MD PHD study chair
First Affiliated Hospital, Sun Yat-Sen University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing part1:teprenone, part1:EAC-T and part1:EA-EMC-T in people with Non-steroidal Anti-inflammatory Drug Adverse Reaction, run by Sun Yat-sen University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
part1:the total proportion of peptic ulcers after treatment (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01547559, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2014.