Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2026-01-01 @ 6:21 AM
Study NCT ID:
NCT04297293
Status:
UNKNOWN
Last Update Posted:
2021-12-22
First Post:
2020-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ramosetron OD Tablet and Postdischarge Nausea and Vomiting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C071315', 'term': 'ramosetron'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 138}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2022-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-21', 'studyFirstSubmitDate': '2020-03-02', 'studyFirstSubmitQcDate': '2020-03-03', 'lastUpdatePostDateStruct': {'date': '2021-12-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change in the occurrence of postoperative nausea', 'timeFrame': 'Postoperative 30 minute, 3 hour, 24 hour, and 48 hour'}, {'measure': 'The change in the occurrence of postoperative vomiting', 'timeFrame': 'Postoperative 30 minute, 3 hour, 24 hour, and 48 hour'}], 'secondaryOutcomes': [{'measure': 'The change in the severity of postoperative nausea', 'timeFrame': 'Postoperative 30 minute, 3 hour, 24 hour, and 48 hour', 'description': 'Numerical rating scale range from 0 to 100 (0 = no pain, 100 = the most severe pain imaginable)'}, {'measure': "The change of patient's satisfaction score", 'timeFrame': 'Postoperative 30 minute, 3 hour, 24 hour, and 48 hour', 'description': 'Numerical rating scale range from 0 to 100 (0 = no pain, 100 = the most severe pain imaginable)'}, {'measure': 'The change in the number of postoperative administration of rescue antiemetic drug', 'timeFrame': 'Postoperative 30 minute, 3 hour, 24 hour, and 48 hour'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Day Surgery']}, 'referencesModule': {'references': [{'pmid': '35546414', 'type': 'DERIVED', 'citation': 'Shin HJ, Park YH, Chang M, Chae YJ, Lee HT, Lee OH, Min SK, Do SH. Effects of ramosetron orally disintegrating tablets on the prophylaxis of post-discharge nausea and/or vomiting in female patients undergoing day surgery under general anesthesia: a randomized controlled trial. Perioper Med (Lond). 2022 May 12;11(1):17. doi: 10.1186/s13741-022-00251-6.'}]}, 'descriptionModule': {'briefSummary': 'Postoperative nausea and vomiting after general anesthesia is one of the common anesthetic complications. If the patient is discharged from the hospital after surgery, proper treatment may be delayed or impossible if nausea and vomiting occurred. Thus, it is necessary to prevent these symptoms beforehand. Patients who underwent day-surgery will be treated with prophylactic ramosetron orally disintegrating tablets to determine whether the frequency of nausea and vomiting is decreased when the patient returned home after discharge.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who undergo day-surgery under general anesthesia and are discharged on the day of surgery\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Patients who are taking other serotonin receptor antagonists\n* Patients who have galactose intolerance or Lapp lactase deficiency\n* patients who have glucose-galactose malabsorption'}, 'identificationModule': {'nctId': 'NCT04297293', 'briefTitle': 'Ramosetron OD Tablet and Postdischarge Nausea and Vomiting', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Effects of Ramosetron Orally Disintegrating Tablet on the Prophylaxis of Postdischarge Nausea and Vomiting in High-risk Patients Undergoing Day Surgery Under General Anesthesia', 'orgStudyIdInfo': {'id': 'B-2002/594-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ramosetron-ODT', 'interventionNames': ['Drug: Ramosetron']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'Ramosetron', 'type': 'DRUG', 'description': 'Ramosetron orally disintegrating tablet 0.1 mg is administered after discharge (postoperative day 1 and day 2)', 'armGroupLabels': ['Ramosetron-ODT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13620', 'city': 'Seongnam-si', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hyun-Jung Shin, Ph.D., M.D.', 'role': 'CONTACT', 'email': 'hjshin.anesth@gmail.com', 'phone': '82317877499'}], 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'centralContacts': [{'name': 'Hyun-Jung Shin, MD., PhD.', 'role': 'CONTACT', 'email': 'hjshin.anesth@gmail.com', 'phone': '82317877499'}], 'overallOfficials': [{'name': 'Hyun-Jung Shin, MD., PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Hyun-Jung Shin', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}