Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2025-12-24 @ 4:01 PM
Study NCT ID:
NCT06543966
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-09
First Post:
2024-07-17
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Study of Aprepitant Injection for Prevention of Post-operative Nausea and Vomiting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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': 'D000077608', 'term': 'Aprepitant'}], 'ancestors': [{'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parrallel Assignment'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 486}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10-28', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2026-03-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-05', 'studyFirstSubmitDate': '2024-07-17', 'studyFirstSubmitQcDate': '2024-08-05', 'lastUpdatePostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of participants with treatment-related adverse events as assessed by NIH', 'timeFrame': 'Day 0 to Day14', 'description': 'Safety was assessed by Adverse events (AEs) were recorded after administration.'}], 'primaryOutcomes': [{'measure': 'Complete response (CR) rates over 24 hours after the end of surgery', 'timeFrame': '0-24 hours after the end of surgery', 'description': 'Complete response (defined as no emetic episodes and no use of rescue therapy)'}], 'secondaryOutcomes': [{'measure': 'Proportion of participants who have no nausea in the 0 to 24 hours following the end of surgery', 'timeFrame': '0-24 hours after the end of surgery', 'description': 'No nausea（defined as a visual analogue scale (VAS) nausea score \\< 1.）'}, {'measure': 'Proportion of participants who have significant nausea in the 0 to 24 hours following the end of surgery', 'timeFrame': '0-24 hours after the end of surgery', 'description': 'Significant nausea（defined as a visual analogue scale (VAS) nausea score≥4）'}, {'measure': 'Proportion of participants who have no vomiting or retching in the 0 to 24 hours following the end of surgery', 'timeFrame': '0-24 hours after the end of surgery', 'description': 'No vomiting or retching（Defined as whether or not use remedy treatment had no vomiting）'}, {'measure': 'Proportion of participants who use the remedial treatment in the 0 to 24 hours following the end of surgery', 'timeFrame': '0-24 hours after the end of surgery'}, {'measure': 'Time to treatment failure in the 0 to 24 hours following the end of surgery', 'timeFrame': '0-24 hours after the end of surgery', 'description': 'defined as the time to the first episode of vomiting (vomiting or retching) or the time to rescue therapy, whichever occurred first.'}, {'measure': 'Proportion of participants who have no vomiting or retching in the 0 to 48 hours following the end of surgery', 'timeFrame': '0-48 hours after the end of surgery', 'description': 'No vomiting or retching（Defined as whether or not use remedy treatment had no vomiting）'}, {'measure': 'The time to the first episode of vomiting (vomiting or retching) in the 0 to 48 hours following the end of surgery', 'timeFrame': '0-48 hours after the end of surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post-operative Nausea and Vomiting (PONV)']}, 'descriptionModule': {'briefSummary': 'A randomized, double-blind, placebo-controlled, multi-center phase III study to compare the efficacy and safety of aprepitant injection and placebo in the prevention of post-operative nausea and vomiting (PONV).,', 'detailedDescription': 'In this study, a randomized, double-blind, placebo-controlled multicenter study will be conducted to evaluate the efficacy and safety of aprepitant injection in the prevention of post-operative nausea and vomiting (PONV).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge ≥18 and ≤75 years old; 18 \\< BMI≤30kg/m\\^2, body weight ≥45kg; laparoscopic gynecologic or abdominal surgery under general anesthesia that was expected to last at least 1 hour.\n\nexpected or agreed to stay in the hospital for 24 hours or more after surgery;\n\nExclusion Criteria:\n\ndiagnostic surgery; scheduled for postoperative transfer to an intensive care unit; requiring placement of a nasogastric or orogastric tube after surgery; Post-operative vomiting may pose significant risk;'}, 'identificationModule': {'nctId': 'NCT06543966', 'briefTitle': 'Efficacy and Safety Study of Aprepitant Injection for Prevention of Post-operative Nausea and Vomiting', 'organization': {'class': 'INDUSTRY', 'fullName': 'CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Multi-center Phase III Study to Evaluate the Efficacy and Safety of Aprepitant Injection in the Prevention of Post-operative Nausea and Vomiting', 'orgStudyIdInfo': {'id': 'SYH9053-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aprepitant Injection', 'description': 'Before anesthesia induction, 4.4ml(32mg） was given by a single intravenous injection, which was completed within 30 seconds', 'interventionNames': ['Drug: Aprepitant Injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Before anesthesia induction, 4.4ml(0mg）was given by a single intravenous injection, which was completed within 30 seconds', 'interventionNames': ['Drug: Aprepitant Injection Placebo']}], 'interventions': [{'name': 'Aprepitant Injection', 'type': 'DRUG', 'description': 'Before anesthesia induction, 4.4ml(32mg） was given by a single intravenous injection, which was completed within 30 seconds', 'armGroupLabels': ['Aprepitant Injection']}, {'name': 'Aprepitant Injection Placebo', 'type': 'DRUG', 'description': 'Before anesthesia induction, 4.4ml(0mg） was given by a single intravenous injection, which was completed within 30 seconds', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'xiangdong chen, Doctor of Medicine(M.D.)', 'role': 'CONTACT', 'email': 'xiangdongchen2013@163.com', 'phone': '+86-027-85726300'}, {'name': 'Clinical Trials Information Group officer', 'role': 'CONTACT', 'email': 'ctr-contact@cspc.cn', 'phone': '86-0311-69085587'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}