Ignite Creation Date:
2025-12-24 @ 7:15 PM
Ignite Modification Date:
2025-12-30 @ 4:49 AM
Study NCT ID:
NCT01020903
Status:
COMPLETED
Last Update Posted:
2023-11-22
First Post:
2009-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Aprepitant for Post-operative Nausea
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D014839', 'term': 'Vomiting'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077608', 'term': 'Aprepitant'}, {'id': 'D000073893', 'term': 'Sugars'}], 'ancestors': [{'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'msilverberg@siuh.edu', 'phone': '718-226-6629', 'title': 'Michael Silverberg/Principal Investigator', 'organization': 'Staten Island University Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Aprepitant', 'description': 'Aprepitant: 40 mg po pre-op Please be advised that the investigator of the study entitled "Aprepitant for Post-operative Nausea" NCT01020903 left the institution in 2011. Normally, to update this record in clinicaltrial.gov, we would go to the IRB records. However, the IRB records of the reviewing IRB (Staten Island University Hospital IRB) were destroyed in Hurricane Sandy in October 2012. This information was provided to FDA and OHRP when the event occurred in 2012. Thus, we do not have any information to use to update the records.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo: Orally, pre-op Please be advised that the investigator of the study entitled "Aprepitant for Post-operative Nausea" NCT01020903 left the institution in 2011. Normally, to update this record in clinicaltrial.gov, we would go to the IRB records. However, the IRB records of the reviewing IRB (Staten Island University Hospital IRB) were destroyed in Hurricane Sandy in October 2012. This information was provided to FDA and OHRP when the event occurred in 2012. Thus, we do not have any information to use to update the records.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Post-operative Nausea and Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Aprepitant', 'description': 'Aprepitant: 40 mg po pre-op'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Orally, pre-op'}], 'timeFrame': '1 year', 'description': 'Records for this study are no longer available to the sponsor to update this study record as they were destroyed in Hurricane Sandy in October 2012. This information was provided to FDA and OHRP when the event occurred in 2012. Thus, we do not have any information to use to update the records. In addition, the PI for this study is no longer with the institution and no contact information is available.', 'reportingStatus': 'POSTED', 'populationDescription': 'Records for this study are no longer available as they were destroyed in Hurricane Sandy in 10/2012- we do not have any information to use to update the records. The PI for this study is no longer with the institution and no contact information is available. Since we cannot verify the # of participants analyzed, the numbers were changed to "0".'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Aprepitant', 'description': 'Aprepitant: 40 mg po pre-op'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo: Orally, pre-op'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Please be advised that the investigator of the study left the institution in 2011.', 'groupId': 'FG000', 'numSubjects': '100'}, {'comment': 'Please be advised that the investigator of the study left the institution in 2011.', 'groupId': 'FG001', 'numSubjects': '100'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Please be advised that the investigator of the study left the institution in 2011.', 'groupId': 'FG000', 'numSubjects': '100'}, {'comment': 'Please be advised that the investigator of the study entitled left the institution in 2011.', 'groupId': 'FG001', 'numSubjects': '100'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Aprepitant', 'description': 'Aprepitant: 40 mg po pre-op'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo: Orally, pre-op'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years'}, {'title': 'Between 18 and 65 years'}, {'title': '>=65 years'}]}], 'description': 'Records for this study are no longer available to the sponsor to update this study record as they were destroyed in Hurricane Sandy in October 2012. This information was provided to FDA and OHRP when the event occurred in 2012. Thus, we do not have any information to use to update the records. In addition, the PI for this study is no longer with the institution and no contact information is available.'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male and Female'}], 'unitOfMeasure': 'participants'}, {'title': 'Aprepitant vs Placebo', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Records for this study are no longer available to the sponsor to update this study record as they were destroyed in Hurricane Sandy in 10/2012. thus, we do not have any information to use to update the records. PI for this study is no longer with the institution and no contact information is available.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-17', 'studyFirstSubmitDate': '2009-11-24', 'resultsFirstSubmitDate': '2014-05-08', 'studyFirstSubmitQcDate': '2009-11-25', 'lastUpdatePostDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-06-03', 'studyFirstPostDateStruct': {'date': '2009-11-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-operative Nausea and Vomiting', 'timeFrame': '1 year', 'description': 'Records for this study are no longer available to the sponsor to update this study record as they were destroyed in Hurricane Sandy in October 2012. This information was provided to FDA and OHRP when the event occurred in 2012. Thus, we do not have any information to use to update the records. In addition, the PI for this study is no longer with the institution and no contact information is available.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Postoperative Nausea']}, 'referencesModule': {'references': [{'pmid': '10365008', 'type': 'BACKGROUND', 'citation': 'Diemunsch P, Schoeffler P, Bryssine B, Cheli-Muller LE, Lees J, McQuade BA, Spraggs CF. Antiemetic activity of the NK1 receptor antagonist GR205171 in the treatment of established postoperative nausea and vomiting after major gynaecological surgery. Br J Anaesth. 1999 Feb;82(2):274-6. doi: 10.1093/bja/82.2.274.'}]}, 'descriptionModule': {'briefSummary': 'Anesthesia, especially for laparoscopic surgery, can cause post-operative nausea and vomiting. Most patients are given two drugs, decadron and ondansetron, to try to minimize this. This study is to determine if a new drug, aprepitant, would add any benefit in terms of post-op nausea prevention. All laparoscopic cholecystectomy study patients will receive decadron and ondansetron. Half the patients will receive aprepitant in addition. The other half will receive placebo. The study will be randomized and double-blind.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Laparoscopic cholecystectomy patients.\n* Must be able to swallow a pill.\n\nExclusion Criteria:\n\n* Liver failure,\n* Age less than 18.\n* Pregnancy, breast-feeding.\n* Pre-op vomiting.\n* Allergy to aprepitant.\n* Need for post-op gastric drainage.\n* Use of drugs that interact with aprepitant.'}, 'identificationModule': {'nctId': 'NCT01020903', 'briefTitle': 'Aprepitant for Post-operative Nausea', 'organization': {'class': 'OTHER', 'fullName': 'Northwell Health'}, 'officialTitle': 'Aprepitant vs. Placebo for the Prevention of Postoperative Nausea and Vomiting: a Randomized, Double-blind Study in Patients Undergoing Laparoscopic Cholecystectomy', 'orgStudyIdInfo': {'id': '09-045'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Aprepitant', 'interventionNames': ['Procedure: Aprepitant']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Aprepitant', 'type': 'PROCEDURE', 'otherNames': ['Emend'], 'description': '40 mg po pre-op', 'armGroupLabels': ['Aprepitant']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Sugar pill'], 'description': 'Orally, pre-op', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10305', 'city': 'Staten Island', 'state': 'New York', 'country': 'United States', 'facility': 'Staten Island University Hospital', 'geoPoint': {'lat': 40.56233, 'lon': -74.13986}}], 'overallOfficials': [{'name': 'Michael B Silverberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Staten Island University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwell Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'Staten Island University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}