Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-25 @ 5:36 PM
Study NCT ID:
NCT05376904
Status:
COMPLETED
Last Update Posted:
2023-03-20
First Post:
2022-05-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Trial of HR18034 for Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'HR18034 compared with active comparator'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-10-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-16', 'studyFirstSubmitDate': '2022-05-11', 'studyFirstSubmitQcDate': '2022-05-11', 'lastUpdatePostDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC of Pain Intensity in rest state', 'timeFrame': '0~72 hours after administration', 'description': 'Pain intensity will be evaluated using an 11-point (0-10) Numeric Pain Rating Scale (NPRS), with higher numbers indicating a higher pain intensity, administered over 72 hours.'}], 'secondaryOutcomes': [{'measure': 'AUC of Pain Intensity in rest state', 'timeFrame': '0~24 hours，0~48 hours after administration', 'description': 'AUC of Pain Intensity in rest state'}, {'measure': 'AUC of Pain Intensity in move state', 'timeFrame': '0~24 hours，0~48 hours，0~72 hours after administration', 'description': 'AUC of Pain Intensity in move state'}, {'measure': 'Pain intensity in rest state assessed using an 11-point NPRS ranging', 'timeFrame': '0~72 hours after administration', 'description': '11-point NPRS ranging from a score of 0 to 10'}, {'measure': 'Pain intensity in move state assessed using an 11-point NPRS ranging', 'timeFrame': '0~72 hours after administration', 'description': '11-point NPRS ranging from a score of 0 to 10'}, {'measure': "Proportion of subjects who doesn't recive rescue analgesic", 'timeFrame': '0~72 hours after administration'}, {'measure': "Participant's satisfaction score for analgesia treatment", 'timeFrame': '72-hours'}, {'measure': "Investigator's satisfaction score for analgesia treatment", 'timeFrame': '72-hours'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postsurgical Pain Management']}, 'descriptionModule': {'briefSummary': 'The study is being conducted to evaluate the efficacy, and safety of HR18034 for postoperative analgesia in subjects undergoing hemorrhoidectomy. To explore the reasonable dosage of HR18034 for postoperative analgesia in subjects undergoing hemorrhoidectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Able and willing to provide a written informed consent\n2. Subjects requiring hemorrhoidectomy under subarachnoid anesthesia\n3. 18 kg/m2 ≤ BMI ≤ 28 kg/m2\n4. Conform to the ASA Physical Status Classification\n5. Women of childbearing age have a negative pregnancy test and are not nursing\n\nExclusion Criteria:\n\n1. Subjects with a history of myocardial infarction or unstable angina pectoris\n2. Subjects with atrioventricular block or cardiac insufficiency\n3. Subjects with a history of ischemic stroke or transient ischemic attack\n4. Subjects with a history of mental illness and a history of cognitive impairment epilepsy\n5. Subjects with concurrent painful physical condition that may affect postoperative pain assessment\n6. Subjects with myelopathy or spinal disease\n7. Subjects with a history of hemorrhoidectomy\n8. Abnormal values in the laboratory\n9. Subject with a history of substance abuse and drug abuse\n10. Subject with refractory hypertension\n11. History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics, opioids, or other drugs that may used in study\n12. History of substance abuse, drug use and/or alcohol abuse\n13. HBsAg, HCVAb, HIV antibody and syphilis antibody tested positive during screening period;\n14. Participated in clinical trials of other drugs (received experimental drugs)\n15. The inestigators determined that other conditions were inappropriate for participation in this clinical trial'}, 'identificationModule': {'nctId': 'NCT05376904', 'briefTitle': 'A Trial of HR18034 for Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Hengrui Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Phase 2, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Controlled Study to Evaluate the Efficacy and Safety of Local Administration of HR18034 for Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy', 'orgStudyIdInfo': {'id': 'HR18034-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HR18034 dose 1', 'interventionNames': ['Drug: HR18034']}, {'type': 'EXPERIMENTAL', 'label': 'HR18034 dose 2', 'interventionNames': ['Drug: HR18034']}, {'type': 'EXPERIMENTAL', 'label': 'HR18034 dose 3', 'interventionNames': ['Drug: HR18034']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ropivacaine HCl', 'interventionNames': ['Drug: ropivacaine HCl.']}], 'interventions': [{'name': 'HR18034', 'type': 'DRUG', 'description': 'HR18034 low dose', 'armGroupLabels': ['HR18034 dose 1']}, {'name': 'HR18034', 'type': 'DRUG', 'description': 'HR18034 midium dose', 'armGroupLabels': ['HR18034 dose 2']}, {'name': 'HR18034', 'type': 'DRUG', 'description': 'HR18034 high dose', 'armGroupLabels': ['HR18034 dose 3']}, {'name': 'ropivacaine HCl.', 'type': 'DRUG', 'description': 'ropivacaine HCl.', 'armGroupLabels': ['ropivacaine HCl']}]}, 'contactsLocationsModule': {'locations': [{'zip': '230000', 'city': 'Hefei', 'state': 'Anhui', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Anhui Medical University', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'zip': '100005', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Tongren Hospital Affiliated to Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '523000', 'city': 'Dongguan', 'state': 'Guangdong', 'country': 'China', 'facility': "Dongguan people's Hospital", 'geoPoint': {'lat': 23.01797, 'lon': 113.74866}}, {'zip': '530000', 'city': 'Nanning', 'state': 'Guangxi', 'country': 'China', 'facility': "Nanning Second People's Hospital", 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}, {'zip': '550000', 'city': 'Guiyang', 'state': 'Guizhou', 'country': 'China', 'facility': 'The Affiliated Hospital of Guizhou Medical University', 'geoPoint': {'lat': 26.58333, 'lon': 106.71667}}, {'zip': '050000', 'city': 'Shijiazhuang', 'state': 'Hebei', 'country': 'China', 'facility': 'Traditional Chinese Medicine Hospital of Hebei Province', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'zip': '442099', 'city': 'Shiyan', 'state': 'Hubei', 'country': 'China', 'facility': 'Shiyan Taihe Hospital', 'geoPoint': {'lat': 32.6475, 'lon': 110.77806}}, {'zip': '415000', 'city': 'Changde', 'state': 'Hunan', 'country': 'China', 'facility': "the first People's Hospital of Changde", 'geoPoint': {'lat': 29.03205, 'lon': 111.69844}}, {'zip': '410000', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'The Third Xiangya Hospital of Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '225300', 'city': 'Taizhou', 'state': 'Jiangsu', 'country': 'China', 'facility': "Taizhou People's Hospital", 'geoPoint': {'lat': 32.49069, 'lon': 119.90812}}, {'zip': '116001', 'city': 'Dalian', 'state': 'Liaoning', 'country': 'China', 'facility': 'Affiliated Zhongshan Hospital of Dalian University', 'geoPoint': {'lat': 38.91222, 'lon': 121.60222}}, {'zip': '110000', 'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'General Hospital of Northern Theater Command', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '250000', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'Central Hospital Affiliated to Shandong First Medical University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '710061', 'city': 'Xi’an', 'state': 'Shanxi', 'country': 'China', 'facility': "the First Affiliated Hospital of Xi'An Jiaotong University", 'geoPoint': {'lat': 35.99785, 'lon': 113.52486}}, {'zip': '710077', 'city': 'Xi’an', 'state': 'Shanxi', 'country': 'China', 'facility': "The First Affiliated Hospital of Xi'an Medical University", 'geoPoint': {'lat': 35.99785, 'lon': 113.52486}}, {'zip': '610072', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': "Sichuan Provincial People's Hospital", 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '314000', 'city': 'Jiaxing', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Jiaxing Second Hospital', 'geoPoint': {'lat': 30.7522, 'lon': 120.75}}, {'zip': '315040', 'city': 'Ningbo', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Li Huili Hospital of Ningbo Medical Center', 'geoPoint': {'lat': 29.87819, 'lon': 121.54945}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Hengrui Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}