Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2026-01-05 @ 5:21 PM
Study NCT ID:
NCT01668069
Status:
COMPLETED
Last Update Posted:
2016-04-06
First Post:
2012-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ondansetron VS Doxylamine and Pyridoxine in Treating Nausea of Pregnancy
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'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-04', 'studyFirstSubmitDate': '2012-08-15', 'studyFirstSubmitQcDate': '2012-08-15', 'lastUpdatePostDateStruct': {'date': '2016-04-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of nausea on the VAS (Visual Analog Scale)', 'timeFrame': '5 days'}], 'secondaryOutcomes': [{'measure': 'Reduction in vomiting on the VAS', 'timeFrame': '5 days'}, {'measure': 'Any adverse effects caused by the study medications.', 'timeFrame': '5 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['nausea', 'vomiting', 'pregnancy', 'ondansetron', 'doxylamine', 'vitamin B6', 'pyridoxine'], 'conditions': ['Vomiting of Pregnancy']}, 'referencesModule': {'references': [{'pmid': '25198265', 'type': 'DERIVED', 'citation': 'Oliveira LG, Capp SM, You WB, Riffenburgh RH, Carstairs SD. Ondansetron compared with doxylamine and pyridoxine for treatment of nausea in pregnancy: a randomized controlled trial. Obstet Gynecol. 2014 Oct;124(4):735-742. doi: 10.1097/AOG.0000000000000479.'}]}, 'descriptionModule': {'briefSummary': 'Our purpose is to determine whether ondansetron, a commonly used antiemetic, is equivalent in efficacy to the combination of pyridoxine and doxylamine, the currently recommended first line therapy for nausea and vomiting in pregnancy by the American Congress of Obstetricians and Gynecologists (ACOG). Since both treatments are safe in pregnancy, many physicians are using ondansetron as first line in practice. Despite this practice and the recommendations from ACOG, there is not data to suggest that ether practice is superior. This will be the first prospective, randomized, double blind, controlled trial comparing the two treatments. We hypothesize that ondansetron will be equally efficacious in reducing nausea and episodes of emesis. By alleviating nausea and vomiting associated with pregnancy, patients will likely benefit from less Emergency Department visits, urgent clinic visits, and admissions for progression to hyperemesis gravidarum.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women who are less than 16 weeks pregnant by last menstrual period or ultrasound\n* Greater than 18 years of age\n* English speaking\n* No significant visual or hearing impairment\n* Requesting treatment for nausea associated with pregnancy\n\nExclusion Criteria:\n\n* If nausea or vomiting preexisted the pregnancy\n* Requires hospitalization at the time of initial enrollment\n* Already taking anti-emetics to include metoclopramide, ondansetron, doxylamine, pyridoxine, or promethazine\n* The patient has an allergy to either study regimen\n* If they are unable to return for a follow up visit in 1 week'}, 'identificationModule': {'nctId': 'NCT01668069', 'briefTitle': 'Ondansetron VS Doxylamine and Pyridoxine in Treating Nausea of Pregnancy', 'organization': {'class': 'FED', 'fullName': 'United States Naval Medical Center, San Diego'}, 'officialTitle': 'Is Zofran Superior to Pyridoxine at Reducing Nausea and Vomiting in Pregnancy', 'orgStudyIdInfo': {'id': 'CIP#NMCSD.2011.0151'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ondansetron', 'description': 'study drug', 'interventionNames': ['Drug: Ondansetron']}, {'type': 'NO_INTERVENTION', 'label': 'Doxylamine and Pyridoxine (vitamin B6)', 'description': 'other nausea treatment in use'}], 'interventions': [{'name': 'Ondansetron', 'type': 'DRUG', 'otherNames': ['Zofran'], 'description': 'Ondansetron 4mg and a placebo capsule to be taken orally every 8 hours for 5 days.', 'armGroupLabels': ['Ondansetron']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92134', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Naval Medical Center, San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Lauren G Oliveira, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'United States Naval Medical Center, San Diego'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'United States Naval Medical Center, San Diego', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}