Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:48 PM
Study NCT ID:
NCT01060267
Status:
COMPLETED
Last Update Posted:
2010-02-02
First Post:
2009-12-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intravenous Erythromycin Before Endoscopy in Patients With Variceal Bleeding: A Randomized, Double-Blind Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}], 'ancestors': [{'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-02-01', 'studyFirstSubmitDate': '2009-12-29', 'studyFirstSubmitQcDate': '2010-02-01', 'lastUpdatePostDateStruct': {'date': '2010-02-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary end point was to determine the effect of erythromycin on gastric cleansing and thereby quality of endoscopic visualization, reflecting the ease with which the procedure was performed in a clear stomach.', 'timeFrame': 'For upto 45 minutes from start to end of endoscopy'}], 'secondaryOutcomes': [{'measure': 'The secondary end points were; 1. the need for second look endoscopy & number of blood units transfused within 24 hours after initial endoscopy; 3. Incidence of endoscopy & drug related complications and length of hospital stay.', 'timeFrame': 'Five to seven days of hospitalization'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Variceal Bleeding']}, 'referencesModule': {'references': [{'pmid': '21145052', 'type': 'DERIVED', 'citation': 'Altraif I, Handoo FA, Aljumah A, Alalwan A, Dafalla M, Saeed AM, Alkhormi A, Albekairy AK, Tamim H. Effect of erythromycin before endoscopy in patients presenting with variceal bleeding: a prospective, randomized, double-blind, placebo-controlled trial. Gastrointest Endosc. 2011 Feb;73(2):245-50. doi: 10.1016/j.gie.2010.09.043. Epub 2010 Dec 8.'}]}, 'descriptionModule': {'briefSummary': 'Objectives:\n\nBlood in stomach \\& oesophagus in patients with variceal bleeding often obscures the endoscopic view \\& makes endoscopic intervention difficult to perform. Erythromycin, a motilin agonist induces gastric emptying. The aim of this study was to assess the effect of Erythromycin on endoscopic visibility and its outcome.', 'detailedDescription': 'Methods:\n\nAdult patients with liver cirrhosis or stigmata of chronic liver disease presenting with hematemesis and or melena within previous 12 hours were randomized in a double blind trial to receive either 125 mg erythromycin or placebo 30 minutes before endoscopy. The primary end points were endoscopic visibility assessed by objective scoring system \\& mean endoscopy duration. Secondary end points were need for repeat endoscopy and blood transfusions within 24 hours of first endoscopy , endoscopy related complications and length of hospital stay.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients with liver cirrhosis or stigmata of chronic liver disease presenting with hematemesis and or melena within previous 12 hours with\n* Age \\>18 years\n* Informed consent\n* Hemodynamically stable patient at the time of endoscopy after resuscitation.\n\nExclusion Criteria:\n\n* Known allergy to erythromycin\n* Prior gastric lavage on admission\n* Current use of antiarrhythmic drugs\n* Prior gastric surgery\n* Previous history of cardiac arrhythmias\n* Concomitant use of antihistaminic drugs with possible drug interactions with erythromycin\n* Prior use of other prokinetic agents\n* Pregnancy or lactation'}, 'identificationModule': {'nctId': 'NCT01060267', 'briefTitle': 'Intravenous Erythromycin Before Endoscopy in Patients With Variceal Bleeding: A Randomized, Double-Blind Trial', 'organization': {'class': 'OTHER_GOV', 'fullName': 'King Abdulaziz Medical City'}, 'officialTitle': 'Effect of Intravenous Bolus Infusion of Erythromycin Prior to Endoscopy in Patients Presenting With Variceal Bleeding: A Prospective, Randomized, Double- Blind ,Placebo Controlled, Trial', 'orgStudyIdInfo': {'id': 'RC06/019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Erythromycin', 'description': 'The patients in erythromycin group received intravenous bolus infusion of 125 mg of erythromycin lactobionate in 50 ml of normal saline', 'interventionNames': ['Drug: Erythromycin']}, {'type': 'NO_INTERVENTION', 'label': 'Placebo Group endoscopic therapy', 'description': 'Endoscopic therapy of variceal bleeding.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Erythromycin', 'type': 'DRUG', 'otherNames': ['Macrolide Antibiotic'], 'description': 'The patients in erythromycin group received intravenous bolus infusion of 125 mg of erythromycin lactobionate in 50 ml of normal saline', 'armGroupLabels': ['Erythromycin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'patients in placebo group 50ml of normal saline over 10 minutes, 1/2 hour before endoscopy.', 'armGroupLabels': ['Placebo Group endoscopic therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22490', 'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'King Abdul Aziz Medical City', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}], 'overallOfficials': [{'name': 'Ibrahim H Altraif, MBBS, FRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'King Abdulaziz Medical City'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Abdulaziz Medical City', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Dr. Ibrahim H Altraif', 'oldOrganization': 'King Abdul Aziz Medical City, National Guard Health Affairs, Saudi Arabia.'}}}}