Ignite Creation Date:
2025-12-24 @ 2:29 PM
Ignite Modification Date:
2025-12-30 @ 6:14 AM
Study NCT ID:
NCT01547559
Status:
UNKNOWN
Last Update Posted:
2014-10-21
First Post:
2012-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Research for Prevention and Treatment of NSAIDs Related Gastrointestinal Side Effects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 369}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'lastUpdateSubmitDate': '2014-10-20', 'studyFirstSubmitDate': '2012-03-07', 'studyFirstSubmitQcDate': '2012-03-07', 'lastUpdatePostDateStruct': {'date': '2014-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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'}], 'secondaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Non-steroidal Anti-inflammatory Drug Adverse Reaction']}, 'referencesModule': {'references': [{'pmid': '25660821', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'part1:\n\nInclusion Criteria:\n\n1. informed consents be given before treatment\n2. NSAIDs taking patients\n3. not taking PPI or other digestive drugs during previous 1 months\n4. age ranging from 18～80 years old\n\nExclusion Criteria:\n\n1. having any severe acute or chronic complications\n2. renal dysfunction, blood creatinine≥150µmol/L\n3. blood aminotransferase level rising up(more than 2 times of the normal level)\n4. any severe cardiac disease including congestive cardiac failure, unstable angina and myocardial infarct in 12 months\n5. serious hypertension (systolic pressure≥180mmHg and/ or diastolic pressure≥110mmHg)\n6. chronic or acute pancreatic disease\n7. severe systematic diseases or malignant tumor\n8. allergic to the drugs using in the trial\n9. any factors interfering the result\n10. female patients incline to be pregnant\n11. being treated with drugs influencing gastroenterological conditions.\n12. poor compliance part2:\n\nInclusion Criteria:\n\n1.18 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\n\nExclusion Criteria:\n\n1. Patients were excluded if they had a history of peptic ulcer or gastrointestinal bleeding\n2. had serious liver, kidney, heart, or lung disease\n3. had suspected small-bowel obstruction\n4. had a history of gastrointestinal surgery except for appendectomy\n5. had a drug addiction or alcoholism; were pregnant or hoped to become pregnant during the study period\n6. were taking anti-secretory drugs such as PPIs or H2 receptor antagonists (H2RA), or other gastric mucosal protective drugs\n7. had a lack of consent to the surgery required if the capsule endoscope was retained in the body\n8. were judged to be inappropriate for this study by the investigator'}, 'identificationModule': {'nctId': 'NCT01547559', 'briefTitle': 'Research for Prevention and Treatment of NSAIDs Related Gastrointestinal Side Effects', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Evaluation of Preventive and Treatment Effects of Hp Eradication and Teprenone in Patients Taking NSAIDs', 'orgStudyIdInfo': {'id': '5010-2007005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'part1:blank control', 'description': 'NO maintain drugs with Hp negative patients.'}, {'type': 'EXPERIMENTAL', 'label': 'part1:teprenone 1', 'description': 'maintain treatment with Teprenone for Hp negative patients', 'interventionNames': ['Drug: part1:teprenone']}, {'type': 'EXPERIMENTAL', 'label': 'part1:EAC-T', 'description': 'eradication of Hp with triple treatment', 'interventionNames': ['Drug: part1:EAC-T']}, {'type': 'EXPERIMENTAL', 'label': 'part1：EA-EMC-T', 'description': 'eradication of Hp with sequential therapy', 'interventionNames': ['Drug: part1:EA-EMC-T']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'part1：T-T', 'description': 'Teprenone as maintain drugs for Hp positive patients', 'interventionNames': ['Drug: part1:teprenone']}, {'type': 'EXPERIMENTAL', 'label': 'part2:GGA group', 'description': 'Geranylgeranylacetone plus diclofenac sodium for patients with rheumatic diseases', 'interventionNames': ['Drug: part2:GGA group']}, {'type': 'NO_INTERVENTION', 'label': 'part2:control group', 'description': 'diclofenac sodium only for patients with rheumatic diseases'}], 'interventions': [{'name': 'part1:teprenone', 'type': 'DRUG', 'otherNames': ['teprenone treatment'], 'description': 'Teprenone 50mg tid after meal for Hp negative patients.', 'armGroupLabels': ['part1:teprenone 1']}, {'name': 'part1:EAC-T', 'type': 'DRUG', 'otherNames': ['EAC-T treatment'], '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', 'armGroupLabels': ['part1:EAC-T']}, {'name': 'part1:EA-EMC-T', 'type': 'DRUG', 'otherNames': ['EA-EMC-T treatment'], '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', 'armGroupLabels': ['part1：EA-EMC-T']}, {'name': 'part1:teprenone', 'type': 'DRUG', 'otherNames': ['T-T treatment'], 'description': 'Teprenone 50mg tid after meal for Hp positive patients.', 'armGroupLabels': ['part1：T-T']}, {'name': 'part2:GGA group', 'type': 'DRUG', 'otherNames': ['GGA'], 'description': 'GGA 50mg three times daily plus diclofenac sodium 75mg once a day for patients with rheumatic diseases.', 'armGroupLabels': ['part2:GGA group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510008', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'the first Affiliated Hospital of Sun Yat-Sen university', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'the first Affiliated Hospital of Sun Yat-Sen university', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Minhu Chen, MD PHD', 'role': 'STUDY_CHAIR', 'affiliation': 'First Affiliated Hospital, Sun Yat-Sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'doctor', 'investigatorFullName': 'Xinxin Huang', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}