Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2025-12-24 @ 9:57 PM
Study NCT ID:
NCT00429832
Status:
COMPLETED
Last Update Posted:
2007-02-01
First Post:
2007-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A RCT of Ondansetron and Promethazine in the Treatment of Nausea and Vomiting in the Emergency Department
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009325', 'term': 'Nausea'}, {'id': 'D014839', 'term': 'Vomiting'}], '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': 'D017294', 'term': 'Ondansetron'}, {'id': 'D011398', 'term': 'Promethazine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002227', 'term': 'Carbazoles'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010640', 'term': 'Phenothiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-01', 'completionDateStruct': {'date': '2005-11'}, 'lastUpdateSubmitDate': '2007-01-31', 'studyFirstSubmitDate': '2007-01-31', 'studyFirstSubmitQcDate': '2007-01-31', 'lastUpdatePostDateStruct': {'date': '2007-02-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in nausea on a VAS.'}], 'secondaryOutcomes': [{'measure': 'Change in sedation on a VAS'}, {'measure': 'Change in anxiety on a VAS'}, {'measure': 'Need for rescue medication at 30 minutes'}, {'measure': 'Patient satisfaction at follow-up'}]}, 'conditionsModule': {'keywords': ['Nausea, vomiting, antiemetic'], 'conditions': ['Nausea', 'Vomiting']}, 'referencesModule': {'references': [{'pmid': '18304050', 'type': 'DERIVED', 'citation': 'Braude D, Crandall C. Ondansetron versus promethazine to treat acute undifferentiated nausea in the emergency department: a randomized, double-blind, noninferiority trial. Acad Emerg Med. 2008 Mar;15(3):209-15. doi: 10.1111/j.1553-2712.2008.00060.x.'}]}, 'descriptionModule': {'briefSummary': 'This was a trial comparing two commonly used medications for nausea and vomiting, ondansetron and promethazine, in the Emergency Department.', 'detailedDescription': 'Nausea and vomiting are common complaints in the emergency department (ED). There are many pharmacologic agents used for the treatment of these complaints. None are new nor experimental. Very little research has been done in the ED setting to determine which of these agents is most effective with the least adverse effects. Our own previous research found that droperidol but not prochlorperazine and metoclopramide is more effective than placebo. Because of the recent FDA black box warning added to droperidol, the use of this agent has suddenly ceased in many EDs. Promethazine remains a very commonly used antiemetic in many EDs but one recent study found it less effective than prochlorperazine which was in turn found no more effective than placebo in our own study. As a result many physicians have turned to ondansetron, a newer and more expensive agent. Experience among anesthesiologists and oncologists has shown ondansetron to be highly effective with a minimum of adverse effects. These patient populations, however, are very different from those found in the ED. It is our hypothesis that promethazine and ondansetron are equally effective for the ED treatment of unselected patients with nausea and vomiting with similar rates of adverse effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 or older\n* Chief complaint of nausea or vomiting\n\nExclusion Criteria:\n\n* Age less than 18\n* unable to provide informed consent\n* rate nausea at \\< 40 mm on 100 mm VAS\n* received antiemetic within 24 hours\n* pregnant or possibly pregnant\n* reported allergy to either study medication\n* received more than 1 liter of intravenous fluids\n* their primary ED physician declined to have patient participate'}, 'identificationModule': {'nctId': 'NCT00429832', 'briefTitle': 'A RCT of Ondansetron and Promethazine in the Treatment of Nausea and Vomiting in the Emergency Department', 'organization': {'class': 'OTHER', 'fullName': 'University of New Mexico'}, 'officialTitle': 'A Randomized Controlled Trial of Ondansetron and Promethazine in the Treatment of Nausea and Vomiting in the Emergency Department', 'orgStudyIdInfo': {'id': '03-006'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ondansetron', 'type': 'DRUG'}, {'name': 'promethazine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico Hospital Emergency Department', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}], 'overallOfficials': [{'name': 'Darren A Braude, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of New Mexico'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of New Mexico', 'class': 'OTHER'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}]}}}