Ignite Creation Date:
2025-12-24 @ 5:50 PM
Ignite Modification Date:
2026-01-27 @ 7:25 PM
Study NCT ID:
NCT01568268
Status:
COMPLETED
Last Update Posted:
2013-12-25
First Post:
2012-03-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Therapeutic Efficacy and Safety of Palonosetron in Treatment of Postoperative Nausea and Vomiting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D000077924', 'term': 'Palonosetron'}], 'ancestors': [{'id': 'D011812', 'term': 'Quinuclidines'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007546', 'term': 'Isoquinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 384}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-24', 'studyFirstSubmitDate': '2012-03-29', 'studyFirstSubmitQcDate': '2012-03-30', 'lastUpdatePostDateStruct': {'date': '2013-12-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete response at 24 hr', 'timeFrame': 'at 24 hour after randomization', 'description': 'Complete response means no retching or vomiting and no administration of secondary rescue drug.'}], 'secondaryOutcomes': [{'measure': 'Complete response at 72 hr', 'timeFrame': 'at 72 hour after randomization', 'description': 'Complete response means no retching or vomiting and no administration of secondary rescue drug.'}, {'measure': 'Complete control at 72 hr', 'timeFrame': 'at 72 hour after randomization', 'description': 'Complete control means no retching or vomiting and no nausea with numerical rating scale \\>= 4 and no administration of secondary rescue drug.'}, {'measure': 'Complete control at 24 hr', 'timeFrame': 'at 24 hour after randomization', 'description': 'Complete control means no retching or vomiting and no nausea with numerical rating scale \\>= 4 and no administration of secondary rescue drug.'}, {'measure': 'the incidence of nausea, retching, vomiting', 'timeFrame': 'at 24, 48, 72 hr after randomization', 'description': 'the incidence of nausea with numerical rating scale \\>= 4, retching, vomiting'}, {'measure': 'Time to recovery of nausea, retching, or vomiting', 'timeFrame': 'at 24, 48, 72 hr after randomization', 'description': 'Time to recovery of nausea, retching, or vomiting from administration of palonosetron'}, {'measure': 'the severity of nausea', 'timeFrame': 'at the time of, 24, 48, 72 hour after randomization', 'description': 'the severity of nausea measured by NRS (numerical rating scale)'}, {'measure': 'the incidence of rescue drug use', 'timeFrame': 'at 24, 48, 72 hour after randomization', 'description': 'the incidence of rescue drug use'}, {'measure': 'QOL by modified Osoba Nausea and Emesis Module', 'timeFrame': 'at 24, 48, 72 hour after randomization', 'description': 'QOL by modified Osoba Nausea and Emesis Module'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['palonosetron', 'postoperative nausea and vomiting'], 'conditions': ['Laparoscopic Gynecologic, Abdominal, Other Surgery', 'General Anesthesia']}, 'referencesModule': {'references': [{'pmid': '25037960', 'type': 'DERIVED', 'citation': 'Hahm TS, Hwang JW, Kim WH, Oh EJ, Kim DK, Choi WJ, Kim YH, Ryu JH, Yoo BH, Yon JH. A prospective, randomized, double-blind, multicenter trial to evaluate the therapeutic efficacy and safety of palonosetron in the treatment of postoperative nausea and vomiting over a 72-h period. J Anesth. 2015 Feb;29(1):21-8. doi: 10.1007/s00540-014-1884-9. Epub 2014 Jul 19.'}]}, 'descriptionModule': {'briefSummary': 'This study was designed to evaluate the treatment efficacy and safety of palonosetron for the patients who undergo laparoscopic gynecologic, abdominal or other surgery under general anesthesia.', 'detailedDescription': 'Postoperative nausea and vomiting (PONV) is a frequent complication of surgery, which can produce subject discomfort with medical and economic consequences. This study was designed to evaluate the treatment efficacy and safety of palonosetron for the subjects who undergo gynecologic or simple laparoscopic surgery. As the previous studies of palonosetron evaluated only the prevention of postoperative nausea and vomiting (PONV), there was no evidence-based guideline of palonosetron for treatment of PONV. The aim of the present study is to evaluate the treatment efficacy and safety of palonosetron for the patients who undergo laparoscopic gynecologic, abdominal or other surgery under general anesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 19 years and older, younger than 70 years old\n* American society of Anesthesiologists physical status classification I to III\n* those who undergo laparoscopic gynecologic, abdominal or other surgery under general anesthesia\n* surgery for which anesthesia is expected to last at least 30 minutes\n* if a subject has or may develop prolongation of cardiac conduction intervals, particularly corrected QT interval, he/she may be enrolled at the discretion of the investigator.\n\nExclusion Criteria:\n\n* known hypersensitivity/ contraindication to 5-hydroxytryptamine antagonists or study drug excipient\n* inability to understand or cooperate with the study procedures as determined by the investigator\n* women who are pregnant, nursing or planning to become pregnant, are not using effective birth control, or that have had a positive serum pregnancy test within 7 days prior to surgery day 1.\n* has received any investigational drug within 30 days before study entry\n* having taken any drug with potential antiemetic efficacy within 24 hour prior to anesthetic procedures.\n* any vomiting, retching, or nausea in the 24 hours preceding the administration of anesthesia\n* known or suspected current history of alcohol abuse or drug abuse.\n* any condition, which in the opinion of the investigator would make the subject ineligible for participation in the study'}, 'identificationModule': {'nctId': 'NCT01568268', 'briefTitle': 'Therapeutic Efficacy and Safety of Palonosetron in Treatment of Postoperative Nausea and Vomiting', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'A Randomized, Double Blind, Multicenter Phase III Trial to Evaluate the Therapeutic Efficacy and Safety of Palonosetron in Treatment of Postoperative Nausea and Vomiting', 'orgStudyIdInfo': {'id': '2011-11-112'}, 'secondaryIdInfos': [{'id': 'CJ_ALX_302', 'type': 'OTHER', 'domain': 'CJ Cheiljedang Corporation'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Palonsetron', 'interventionNames': ['Drug: Palonosetron']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: placebo control group']}], 'interventions': [{'name': 'Palonosetron', 'type': 'DRUG', 'otherNames': ['Aloxi (palonosetron)'], 'description': 'palonosetron 0.075 mg intravenous injection over 10 seconds when nausea with NRS \\>= 4, or developement of retching or vomiting more than one time within three hour after the end of surgery.', 'armGroupLabels': ['Palonsetron']}, {'name': 'placebo control group', 'type': 'DRUG', 'otherNames': ['placebo'], 'description': 'placebo intravenous injection over 10 seconds when nausea with NRS \\>= 4, or developement of retching or vomiting more than one time within three hour after the end of surgery.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-710', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Bungdang Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kangpook Samsung Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Sangye Bahk Hospital, Inje School of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Tae Soo Hahm, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Samsung Seoul Hospital, Samsung Medical Center'}, {'name': 'Youn Hong Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kangpook Samsung Hospital, Samsung Medical Center'}, {'name': 'Jung Won Hwang, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}, {'name': 'Joun Heum Yeon, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sange Bahk Hospital, Inje School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'HK inno.N Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}