Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2026-01-03 @ 10:22 PM
Study NCT ID:
NCT02621359
Status:
UNKNOWN
Last Update Posted:
2018-01-03
First Post:
2015-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Two Week Nitazoxanidebased Quadruple Regimen
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004415', 'term': 'Dyspepsia'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C041747', 'term': 'nitazoxanide'}, {'id': 'D064704', 'term': 'Levofloxacin'}, {'id': 'D015242', 'term': 'Ofloxacin'}, {'id': 'D004318', 'term': 'Doxycycline'}, {'id': 'D009853', 'term': 'Omeprazole'}], 'ancestors': [{'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D001562', 'term': 'Benzimidazoles'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-12-30', 'studyFirstSubmitDate': '2015-11-27', 'studyFirstSubmitQcDate': '2015-12-01', 'lastUpdatePostDateStruct': {'date': '2018-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with eradicated helicobacter', 'timeFrame': '1 year', 'description': 'The total number of patients with eradicated helicobacter'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Dyspepsia']}, 'descriptionModule': {'briefSummary': 'Helicobacter pylori (H. pylori) infection is a global health problem as it is associated with peptic ulcers, chronic gastritis, duodenitis, and stomach cancer.\n\nTherefore, the eradication of the pathogen is of critical importance to reduce H. pylori-related complications .\n\nHowever, due to increasing antibiotic resistance, eradication of Helicobacter pylori has become more challenging. With a great decline in the eradication rate of standard triple therapy for Helicobacter pylori to below 70% in many countries.\n\nTreatment with triple therapy, which is the most frequently recommended, fails to eradicate H. pylori in approximately 20% of cases .', 'detailedDescription': 'Designing a new rescue regimen that achieves greater than 85% eradication rate is an important target of current research.\n\nUnfortunately, the most frequently used "rescue" or "salvage" therapy is bismuth quadruple therapy consisting of a proton pump inhibitor (PPI), tetracycline, metronidazole, and bismuth \\[11\\]. This rescue therapy is inexpensive, and relatively effective with average eradication rate of 70% when used as second-line therapy. However, disadvantages of bismuth based quadruple therapy include the large daily number of pills (sometimes exceeding 18 pills), increased dosing frequency (four times daily), and frequent side effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with helicobacter infection.\n* in whom the standard triple therapy (clarithromycin-based triple therapy) failed\n\nExclusion Criteria:\n\n* Patients under 18 or over 65 years of age.\n* Those with co-existing serious illnesses such as liver cirrhosis, uremia and gastrointestinal malignancies\n* pregnancy/lactation\n* having contraindication or allergy to any of the study drugs'}, 'identificationModule': {'nctId': 'NCT02621359', 'briefTitle': 'A Two Week Nitazoxanidebased Quadruple Regimen', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'A Two Week Nitazoxanidebased Quadruple Regimen for Helicobacter Pylori Therapy After Failure of Standard Triple Therapy: A Single Center Experience', 'orgStudyIdInfo': {'id': 'Quadruple therapy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Quadruple therapy', 'description': 'Nitazoxanide (500mg bid), Levofloxacin (500 mg once daily), Omeprazole (40 mg bid) and doxycyclin (100 mg twice daily) were prescribed for 14 days.', 'interventionNames': ['Drug: Nitazoxanide', 'Drug: Levofloxacin', 'Drug: Doxycyclin', 'Drug: Omeprazole']}], 'interventions': [{'name': 'Nitazoxanide', 'type': 'DRUG', 'otherNames': ['Alenia, nitclean, parazoxanide'], 'description': 'Nitazoxanide 500 mg twice daily', 'armGroupLabels': ['Quadruple therapy']}, {'name': 'Levofloxacin', 'type': 'DRUG', 'otherNames': ['Tavanic, levoxin, venaxan.'], 'description': 'Levofloxacin 500 mg once daily', 'armGroupLabels': ['Quadruple therapy']}, {'name': 'Doxycyclin', 'type': 'DRUG', 'otherNames': ['Vibramycin, Doxymycin'], 'description': 'Doxycyclin 100 mg twice daily', 'armGroupLabels': ['Quadruple therapy']}, {'name': 'Omeprazole', 'type': 'DRUG', 'otherNames': ['Omepak, Pepzole, Gasec, Risek.'], 'description': 'Omeprazole 40 mg twice daily', 'armGroupLabels': ['Quadruple therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tanta', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Sherief Abd-Elsalam, lecturer', 'role': 'CONTACT', 'email': 'Sherif_tropical@yahoo.com', 'phone': '00201095159522'}], 'facility': 'Tropical medicine dept.-Tanta university hospital', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'centralContacts': [{'name': 'Sherief Abd-Elsalam, lecturer', 'role': 'CONTACT', 'email': 'sherif_tropical@yahoo.com', 'phone': '00201095159522'}], 'overallOfficials': [{'name': 'Sherief Abd-Elsalam, lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tropical medicine-Tanta university hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Hepatology and Gastroenterology Dept., Tanta university, M.D., Principle investigator', 'investigatorFullName': 'Sherief Abd-Elsalam', 'investigatorAffiliation': 'Tanta University'}}}}