Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2026-01-22 @ 7:44 AM
Study NCT ID:
NCT02894268
Status:
UNKNOWN
Last Update Posted:
2018-09-05
First Post:
2016-08-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Doxycycline- and Furazolidone-containing Quadruple Regimen is Superior of Tailored Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004318', 'term': 'Doxycycline'}, {'id': 'D005664', 'term': 'Furazolidone'}, {'id': 'D064098', 'term': 'Esomeprazole'}, {'id': 'C002791', 'term': 'bismuth tripotassium dicitrate'}], 'ancestors': [{'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D009581', 'term': 'Nitrofurans'}, {'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D023303', 'term': 'Oxazolidinones'}, {'id': 'D010080', 'term': 'Oxazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005663', 'term': 'Furans'}, {'id': 'D009853', 'term': 'Omeprazole'}, {'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-04', 'studyFirstSubmitDate': '2016-08-25', 'studyFirstSubmitQcDate': '2016-09-03', 'lastUpdatePostDateStruct': {'date': '2018-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'H. pylori eradication rate', 'timeFrame': '42 days after start of therapy', 'description': 'Repeat 13-Urea breath test 42 days after H.pylori eradication'}], 'secondaryOutcomes': [{'measure': 'Clinical response as measured by Number of participants whose symptoms disappear or improve after eradication treatment', 'timeFrame': '14 days and 42 days after H.pylori eradication', 'description': 'Number of participants whose symptoms disappear or improve after eradication treatment.'}, {'measure': 'Side effects', 'timeFrame': '14 days after start of therapy', 'description': 'Adverse Events That Are Related to Eradication Treatment'}, {'measure': 'Adherence rate', 'timeFrame': '14 days after start of therapy', 'description': 'Number of patients who take at least 80% drugs'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Helicobacter Pylori Infection']}, 'referencesModule': {'references': [{'pmid': '24849129', 'type': 'BACKGROUND', 'citation': 'Zhang Y, Gao W, Cheng H, Zhang X, Hu F. Tetracycline- and furazolidone-containing quadruple regimen as rescue treatment for Helicobacter pylori infection: a single center retrospective study. Helicobacter. 2014 Oct;19(5):382-6. doi: 10.1111/hel.12143. Epub 2014 May 21.'}, {'pmid': '25801708', 'type': 'RESULT', 'citation': 'Ciccaglione AF, Cellini L, Grossi L, Manzoli L, Marzio L. A Triple and Quadruple Therapy with Doxycycline and Bismuth for First-Line Treatment of Helicobacter pylori Infection: A Pilot Study. Helicobacter. 2015 Oct;20(5):390-6. doi: 10.1111/hel.12209. Epub 2015 Mar 20.'}]}, 'descriptionModule': {'briefSummary': 'Doxycycline- and Furazolidone-containing Quadruple Regimen can be a successful rescue treatment for Helicobacter pylori Infection patients after Failure of several therapy. It is superior of tailored therapy as rescue treatment for helicobacter pylori Infection after failure of several therapy.', 'detailedDescription': 'This study is a prospective, multiple centers, randomized trial. Patients who had failed in previous H. pylori eradication treatment that more than two times will be enrolled in Sir Run Run Shaw Hospital.\n\nPretreatment H. pylori status will be defined by a positive 13 C-urea breath test (13 C-UBT). Patients who had received bismuth compounds, acid inhibitor, or antibiotics during 4 weeks before 13 C-UBT are excluded. Other exclusion criteria included upper gastrointestinal surgery, malignancy, and evidence of blood dyscrasia.\n\nAfter the patient is enrolled the patient will sign the informed consent and receive gastroscopy. More than four biopsy will be given including two in antrum and two in gastric body. One pair of biopsy sample will be sent for the pathology and the other pair is used for H.pylori culture and antibiotics sensitivity. After we get the result of antibiotics sensitivity the patient will be divided randomly into two groups, Regimen A, Regimen B.\n\nThe Regimen A includes esomeprazole (E) 20 mg, doxycycline (D) 100mg, furazolidone (F) 100 mg, and colloidal bismuth subcitrate (B) 100 mg . All drugs are taken twice a day for 14 days. The Regimen B includes two antibiotics based on antibiotic sensitivity of helicobacter pylori culture, colloidal bismuth subcitrate (B) 100 mg, esomeprazole (E) 20 mg. The esomeprazole and bismuth are taken half an hour before a meal and antibiotics after the meal.\n\nAll patients are asked to quit smoking and drinking and forbid eating foods rich in tyramine (e.g., chicken, cheese, pickles, lentils, beans) and seafood during and in 1 week after the treatment.\n\nPatients will be followed up at the 1st day, 14th day, and 4 weeks after the treatment, respectively, and all side effects will be collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. A positive 13 C-urea breath test\n2. Formal H.pylori treatment more than two times\n3. Age \\>18 years\n\nExclusion Criteria:\n\n1. Bismuth compounds, acid inhibitor, or antibiotics during 4 weeks before the patient is enrolled\n2. Allergic to the medications\n3. Upper gastrointestinal surgery history\n4. Serious heart insufficiency, liver insufficiency, renal insufficiency and other serious medical problems\n5. Evidence of blood dyscrasia\n6. Pregnant and lactating women\n7. Can't express his complain correctly and can't cooperate with the researcher"}, 'identificationModule': {'nctId': 'NCT02894268', 'briefTitle': 'Doxycycline- and Furazolidone-containing Quadruple Regimen is Superior of Tailored Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Sir Run Run Shaw Hospital'}, 'officialTitle': 'Doxycycline- and Furazolidone-containing Quadruple Regimen is Superior of Tailored Therapy as Rescue Treatment for Helicobacter Pylori Infection After Failure of Several Therapy', 'orgStudyIdInfo': {'id': '20160513-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Regimen A', 'description': 'esomeprazole (E) 20 mg, doxycycline (D) 100mg, furazolidone (F) 100 mg, and colloidal bismuth subcitrate (B) 100 mg', 'interventionNames': ['Drug: Doxycycline', 'Drug: Furazolidone', 'Drug: Esomeprazole', 'Drug: Colloidal Bismuth Subcitrate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Regimen B', 'description': 'two sensitivity antibiotics based on antibiotic sensitivity of helicobacter pylori culture, colloidal bismuth subcitrate (B) 100 mg, esomeprazole (E) 20 mg', 'interventionNames': ['Drug: Esomeprazole', 'Drug: Colloidal Bismuth Subcitrate', 'Drug: Sensitivity antibiotics']}], 'interventions': [{'name': 'Doxycycline', 'type': 'DRUG', 'otherNames': ['Vibramycin'], 'description': 'Doxycycline 100g po bid', 'armGroupLabels': ['Regimen A']}, {'name': 'Furazolidone', 'type': 'DRUG', 'otherNames': ['Giarlan'], 'description': 'Furazolidone 100mg po bid', 'armGroupLabels': ['Regimen A']}, {'name': 'Esomeprazole', 'type': 'DRUG', 'otherNames': ['Nexium'], 'description': 'Esomeprazole 20mg po bid', 'armGroupLabels': ['Regimen A', 'Regimen B']}, {'name': 'Colloidal Bismuth Subcitrate', 'type': 'DRUG', 'otherNames': ['PIDI'], 'description': 'Bismuth 20mg po bid', 'armGroupLabels': ['Regimen A', 'Regimen B']}, {'name': 'Sensitivity antibiotics', 'type': 'DRUG', 'description': 'Two antibiotics based on antibiotic sensitivity of H.pylori culture, including amoxicillin, clarithromycin, metronidazole, levofloxacin, tetracycline and furazolidone.', 'armGroupLabels': ['Regimen B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weiling Hu, Attending', 'role': 'CONTACT', 'email': 'ringwh@163.com', 'phone': '+86153-9705-9751'}, {'name': 'Weiling Hu, Atrending', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sir Run Run Shaw Hospital,Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Ning Dai, Chief', 'role': 'CONTACT', 'email': '2267454962@qq.com', 'phone': '+86138-6745-7664'}, {'name': 'Weiling Hu, Attending', 'role': 'CONTACT', 'email': 'ringwh@163.com', 'phone': '+86153-9705-9751'}], 'overallOfficials': [{'name': 'Weiling Hu, Attending', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sir Run Run Shaw Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sir Run Run Shaw Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Weiling Hu, MD,PhD', 'investigatorAffiliation': 'Sir Run Run Shaw Hospital'}}}}