Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-28 @ 12:27 AM
Study NCT ID:
NCT00999232
Status:
COMPLETED
Last Update Posted:
2010-01-22
First Post:
2009-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assess the Effect of Erythromycin on the Rate of Success in Placement of a Self-propelled Feeding Tube
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010195', 'term': 'Pancreatitis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004917', 'term': 'Erythromycin'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'lastUpdateSubmitDate': '2010-01-21', 'studyFirstSubmitDate': '2009-10-20', 'studyFirstSubmitQcDate': '2009-10-20', 'lastUpdatePostDateStruct': {'date': '2010-01-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The success rate of spontaneous positioning the tubes tip into the jejunum, beyond Treitz ligament, after 48 hours.'}], 'secondaryOutcomes': [{'measure': 'The success rate of spontaneous positioning the tubes tip into the jejunum, beyond Treitz ligament, after 24 hours.'}, {'measure': 'Adverse events using this self-propelled tube'}]}, 'conditionsModule': {'keywords': ['erythromycin', 'prokinetics', 'nasojejunal tubes', 'Bengmark feeding tube', 'post-pyloric feeding', 'pancreatitis', 'Non-critically ill patients having pancreatitis who require jejunal enteral nutrition'], 'conditions': ['Pancreatitis']}, 'referencesModule': {'references': [{'pmid': '21447772', 'type': 'DERIVED', 'citation': 'van den Bosch S, Witteman E, Kho Y, Tan AC. Erythromycin to promote bedside placement of a self-propelled nasojejunal feeding tube in non-critically ill patients having pancreatitis: a randomized, double-blind, placebo-controlled study. Nutr Clin Pract. 2011 Apr;26(2):181-5. doi: 10.1177/0884533611399924.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effect of erythromycin on the Rate of Success in Placement of a Self-propelled Feeding Tube.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18-80 years\n* Having pancreatitis\n* Require jejunal enteral nutrition\n\nExclusion Criteria:\n\n* Known impaired peristalsis (critically ill patients, postoperative patients, history of surgery of the stomach/duodenum)\n* Pregnancy\n* Hypersensibility to erythromycin\n* Cardiac arrhythmias with a prolonged QT-time\n* Simultaneous usage of drugs impairing peristalsis'}, 'identificationModule': {'nctId': 'NCT00999232', 'briefTitle': 'Assess the Effect of Erythromycin on the Rate of Success in Placement of a Self-propelled Feeding Tube', 'organization': {'class': 'OTHER', 'fullName': 'Canisius-Wilhelmina Hospital'}, 'orgStudyIdInfo': {'id': 'Bengmark_v1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Erythromycin', 'interventionNames': ['Drug: Erythromycin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Erythromycin', 'type': 'DRUG', 'description': 'Subjects receive 4x250mg erythromycin i.v. daily after intubation of a self-propelled feeding tube', 'armGroupLabels': ['Erythromycin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Subjects receive 4x placebo i.v. daily after intubation of a self-propelled feeding tube', 'armGroupLabels': ['Placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Canisius-Wilhelmina Hospital', 'class': 'OTHER'}}}}