Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2025-12-27 @ 7:25 PM
Study NCT ID:
NCT06007066
Status:
COMPLETED
Last Update Posted:
2023-08-23
First Post:
2023-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HSK16149 for Perioperative Analgesia in Orthopedic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 235}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-07-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-17', 'studyFirstSubmitDate': '2023-03-05', 'studyFirstSubmitQcDate': '2023-08-17', 'lastUpdatePostDateStruct': {'date': '2023-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morphine Consumption', 'timeFrame': 'Participants received PCA pump, an average of 24 hours after surgery', 'description': 'IV Patient Controlled Analgesia (PCA) morphine for pain management in the immediate postoperative period for an average of 24 hours after surgery. If PCA is insufficient, rescue analgesia of morphine may be given I.V. as determined by the investigator.\n\nTotal morphine consumption = PCA morphine consumption + rescue analgesia morphine consumption.'}], 'secondaryOutcomes': [{'measure': 'NRS at rest and during exercise', 'timeFrame': '1, 2, 6, 12, 18, and 24 hours after surgery', 'description': 'NRS:0 (no pain) to 10 (worst possible pain)'}, {'measure': 'Time of first rescue analgesia with morphine after surgery', 'timeFrame': 'Within 24 hours after surgery'}, {'measure': 'Incidence of adverse reactions associated with morphine', 'timeFrame': 'Within 24 hours after surgery'}, {'measure': 'The frequency of rescue analgesia with morphine', 'timeFrame': 'Within 24 hours after surgery'}, {'measure': 'The total number of PCA presses and the number of effective PCA presses', 'timeFrame': 'Within 24 hours after surgery'}, {'measure': 'Daily Sleep Interference Scale (DSIS)', 'timeFrame': 'Within 24 hours after surgery', 'description': 'Subjects review their sleep status during the past 12 hours at 8:00 a.m. on the day of surgery.\n\nDSIS: 0 (not affecting sleep) to 10 (unable to sleep)'}, {'measure': 'Subjects analgesic satisfaction score', 'timeFrame': 'Within 24 hours after surgery', 'description': 'Analgesic satisfaction score: 0 (not satisfied) to 10 (very satisfied)'}, {'measure': 'Investigators analgesic satisfaction score', 'timeFrame': 'Within 24 hours after surgery', 'description': 'Analgesic satisfaction score: 0 (not satisfied) to 10 (very satisfied)'}, {'measure': 'Number of participants with treatment-related adverse events(TEAE) as assessed by CTCAE v5.0.', 'timeFrame': 'From enrollment to 72 hours after surgery', 'description': 'Number and severity of AEs, clinical laboratory abnormalities, physical examinations, 12-lead electrocardiograms (ECGs)(including QT Interval,QTc Interval and PR Interval), and vital signs.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post-operative Pain']}, 'descriptionModule': {'briefSummary': 'This study will compare the effect and safety of HSK16149 with placebo on perioperative analgesia in orthopedic surgery, and explore the dosage of HSK16149 capsules for orthopedic analgesia during perioperative period.', 'detailedDescription': 'This study included patients who have orthopedic surgery under general anesthetic, with expected operation time ≤4h.\n\nSubjects were given 40mg or 60mg of HSK16149 or placebo orally the night before surgery, 2h before surgery, 4h and 16h after surgery, for a total of 4 times during the whole treatment period.\n\nSubjects will receive intravenous patient-controlled analgesia (PCA) morphine for pain in the immediate postoperative period. If PCA is insufficient, rescue analgesia of morphine may be given I.V. as determined by the investigator.\n\nAfter the treatment period, the subjects will be followed up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female between the ages of 18 and 75 years (included);\n2. Elective orthopedic surgery under general anesthesia, expected operation time ≤4 hours and postoperative morphine analgesia time ≥24 hours;\n3. 18kg/m\\^2≤BMI≤30 kg/m\\^2;\n4. American Society of Anesthesiologists (ASA) grade I and II;\n\nExclusion Criteria:\n\n1. Any of the following medical histories or conditions prior to screening:\n\n * Long history of chronic pain;\n * history of severe cardiovascular or respiratory disease;\n * history of neurological or psychiatric disorders;\n * history of acute poisoning with alcohol, hypnotics, analgesics or other drugs acting on the central nervous system;\n * major surgery within 3 months;\n * patients with high bleeding risk;\n * history of renal disease treated with dialysis within 28 days before surgery;\n * have active infection within the past 2 weeks;\n2. Use of any of the following medications or treatments:\n\n * opioid analgesics for more than 10 consecutive days within 3 months prior to screening;\n * other analgesics before randomization if the last dose was taken less than 5 half-lives of the drug (according to the label);\n3. Abnormal laboratory tests during screening:\n4. Hypertension that is not adequately controlled by antihypertensive drugs (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg), or systolic blood pressure ≤90 mmHg during screening;\n5. A history of drug abuse, and/or alcohol abuse in the 3 months prior to screening;\n6. Participated in another clinical trial and received IMP within 30 days prior to screening;\n7. Pregnant or lactating women;\n8. Unwillingness to use reliable contraceptive methods from the time of screening until 28 days after the last dose of IMP;'}, 'identificationModule': {'nctId': 'NCT06007066', 'briefTitle': 'HSK16149 for Perioperative Analgesia in Orthopedic Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Haisco Pharmaceutical Group Co., Ltd.'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Placebo-controlled Phase II Study of The Efficacy And Safety of HSK16149 In The Treatment of Patients With Orthopedic Perioperative Analgesia', 'orgStudyIdInfo': {'id': 'HSK16149-204'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Preoperative administration of HSK16149 40mg', 'description': 'HSK16149 40mg will be administered the night before and 2h before surgery', 'interventionNames': ['Drug: HSK16149 capsule']}, {'type': 'EXPERIMENTAL', 'label': 'Preoperative administration of HSK16149 60mg', 'description': 'HSK16149 60mg will be administered the night before and 2h before surgery', 'interventionNames': ['Drug: HSK16149 capsule']}, {'type': 'EXPERIMENTAL', 'label': 'Preoperative and postoperative administration of HSK16149 40mg', 'description': 'HSK16149 40mg will be administered orally the night before surgery, 2h before surgery, 4h and 16h after surgery', 'interventionNames': ['Drug: HSK16149 capsule']}, {'type': 'EXPERIMENTAL', 'label': 'Preoperative and postoperative administration of HSK16149 60mg', 'description': 'HSK16149 60mg will be administered orally the night before surgery, 2h before surgery, 4h and 16h after surgery', 'interventionNames': ['Drug: HSK16149 capsule']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'The placebo will be administered orally the night before surgery, 2h before surgery, 4h and 16h after surgery', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'HSK16149 capsule', 'type': 'DRUG', 'otherNames': ['HSK16149'], 'description': 'Subjects will be given 40mg or 60mg of HSK16149 orally.', 'armGroupLabels': ['Preoperative administration of HSK16149 40mg', 'Preoperative administration of HSK16149 60mg', 'Preoperative and postoperative administration of HSK16149 40mg', 'Preoperative and postoperative administration of HSK16149 60mg']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['HSK16149 placebo'], 'description': 'Subjects will be given HSK16149 placebo orally.', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dongguan', 'state': 'Guangdong', 'country': 'China', 'facility': "Dongguan People's Hospital", 'geoPoint': {'lat': 23.01797, 'lon': 113.74866}}, {'city': 'Foshan', 'state': 'Guangdong', 'country': 'China', 'facility': 'Foshan Fuxing Chancheng Hospital', 'geoPoint': {'lat': 23.02677, 'lon': 113.13148}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The First Affiliated Hospital of Jinan University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guiyang', 'state': 'Guizhou', 'country': 'China', 'facility': 'Affiliated Hospital of Guizhou Medical University', 'geoPoint': {'lat': 26.58333, 'lon': 106.71667}}, {'city': 'Guiyang', 'state': 'Guizhou', 'country': 'China', 'facility': 'Beijing Jishuitan Hospital Guizhou Hospital', 'geoPoint': {'lat': 26.58333, 'lon': 106.71667}}, {'city': 'Zunyi', 'state': 'Guizhou', 'country': 'China', 'facility': 'Zunyi University Affiliated Hospital', 'geoPoint': {'lat': 27.68667, 'lon': 106.90722}}, {'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': "Henan Provincial People's Hospital", 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': "People's Hospital of Wuhan University", 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Wuhan Central Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'Xiangya Third Hospital of Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'city': 'Hengyang', 'state': 'Hunan', 'country': 'China', 'facility': 'The First Affiliated Hospital of South China University', 'geoPoint': {'lat': 26.88946, 'lon': 112.61888}}, {'city': 'Lianyungang', 'state': 'Jiangsu', 'country': 'China', 'facility': "Lianyungang First People's Hospital", 'geoPoint': {'lat': 34.59845, 'lon': 119.21556}}, {'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Nanjing First Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': "Chengdu Second People's Hospital", 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': "Chengdu Third People's Hospital", 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': "Sichuan Provincial People's Hospital", 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Guangyuan', 'state': 'Sichuan', 'country': 'China', 'facility': "Guangyuan First People's Hospital", 'geoPoint': {'lat': 32.44201, 'lon': 105.823}}, {'city': 'Mianyang', 'state': 'Sichuan', 'country': 'China', 'facility': 'Mianyang Central Hospital', 'geoPoint': {'lat': 31.46784, 'lon': 104.68168}}, {'city': 'Yibin', 'state': 'Sichuan', 'country': 'China', 'facility': "Yibin Second People's Hospital", 'geoPoint': {'lat': 28.7593, 'lon': 104.63994}}, {'city': 'Kunming', 'state': 'Yunnan', 'country': 'China', 'facility': "The First People's Hospital of Yunnan Province", 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}, {'city': 'Beijing', 'country': 'China', 'facility': 'Sino-Japanese Friendship Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Haisco Pharmaceutical Group Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}