Ignite Creation Date:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2026-01-06 @ 3:25 PM
Study NCT ID:
NCT03491995
Status:
UNKNOWN
Last Update Posted:
2018-04-10
First Post:
2018-04-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Unique Regimen for Treatment of Helicobacter Pylori Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016481', 'term': 'Helicobacter Infections'}], 'ancestors': [{'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2023-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-07', 'studyFirstSubmitDate': '2018-04-02', 'studyFirstSubmitQcDate': '2018-04-02', 'lastUpdatePostDateStruct': {'date': '2018-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with eradicated Helicobacter infection', 'timeFrame': '6 months', 'description': 'Number of patients with eradicated infection'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Helicobacter Infections']}, 'descriptionModule': {'briefSummary': 'The triple treatment including Proton pump inhibitor (PPI) -clarithromycin and amoxicillin or metronidazole was proposed 30 years ago at the first Maastricht conference to treat helicobacter pylori (H. pylori) infection and since that time, it has become the universal and standard treatment for helicobacter pylori.\n\nHowever, the efficacy of this triple regimen has been seriously challenged, and they are gradually becoming ineffective', 'detailedDescription': 'Growing rates of treatment failure are observed worldwide and the eradication rate of triple therapy has declined over the past few decades. Helicobacter pylori infection has become increasingly resistant to traditional first line treatment regimens because of emerging antibiotic resistance coupled with poor patient compliance with completing the treatment course that decrease H. pylori eradication rates .So there is a considerable interest in evaluating new antibiotic combinations and regimens .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged older than 21 years Presenting by Dyspepsia Infected by H. pylori (as proved by positive stool antigen test) Agreed to participate in the study and signed the consent\n\nExclusion Criteria:\n\n* Patients who have received treatment with proton pump inhibitors within 2 weeks, NSAID or antibiotics within 4 weeks before study entry Patients who had received H pylori treatment before. Patients presenting by upper gastrointestinal bleeding Pregnant females Patients who have significant gastrointestinal, renal, hepatic, cardiovascular, metabolic, hematological disease.'}, 'identificationModule': {'nctId': 'NCT03491995', 'briefTitle': 'A Unique Regimen for Treatment of Helicobacter Pylori Infection', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'A Unique Quadruple Regimen for of Helicobacter Pylori', 'orgStudyIdInfo': {'id': 'Helicobacter study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Quadruple therapy', 'description': 'Moxifloxacin, Nitazoxanide, Omeprazole sodium bicarbonate, Doxycyclin', 'interventionNames': ['Drug: Quadruple therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Classic treatment', 'description': 'Omeprazole, clarithromycin, amoxicillin', 'interventionNames': ['Drug: Classic treatment']}], 'interventions': [{'name': 'Quadruple therapy', 'type': 'DRUG', 'otherNames': ['Moxiflox, Downoprazol, Nanazoxid, Doxymycin'], 'description': 'Moxifloxacin, omeprazole sodium bicarbonate, nitazoxanide, doxycyclin', 'armGroupLabels': ['Quadruple therapy']}, {'name': 'Classic treatment', 'type': 'DRUG', 'otherNames': ['Downoprazol, Emox, Klacid'], 'description': 'Omeprazole, amoxycillin, clarithromycin', 'armGroupLabels': ['Classic treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tanta', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Sherief Abd-elsalam, lecturer', 'role': 'CONTACT', 'email': 'Sherif_tropical@yahoo.com', 'phone': '00201000040794'}], 'facility': 'Sherief Abd-Elsalam', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'centralContacts': [{'name': 'Sherief Abd-Elsalam, MD', 'role': 'CONTACT', 'email': 'sheriefabdelsalam@yahoo.com', 'phone': '00201147773440'}], 'overallOfficials': [{'name': 'Ayman Yousry, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Head of Hepatology and infectious diseases dept.-Cairo University'}, {'name': 'Walied El-Hossary, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hepatology and infectious diseases dept.-Cairo University'}, {'name': 'Mohamed Alboraie, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Internal Medicine dept.-Alazhar University'}, {'name': 'Sherief Abd-Elsalam, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hepatology and Infectious diseases- Tanta University'}, {'name': 'Asem Elfert, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Hepatology and Infectious diseases- Tanta University'}, {'name': 'Hussein A Elamin, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Internal Medicine-Assuit University'}, {'name': 'Mohamed Adel Elbasiony, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Internal Medicine- Mansoura University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sherief Abd-Elsalam', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Investigator', 'investigatorFullName': 'Sherief Abd-Elsalam', 'investigatorAffiliation': 'Tanta University'}}}}