Ignite Creation Date:
2025-12-25 @ 1:42 AM
Ignite Modification Date:
2025-12-26 @ 12:55 AM
Study NCT ID:
NCT07185594
Status:
RECRUITING
Last Update Posted:
2025-11-17
First Post:
2025-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase Ⅱ/Ⅲ Study of HRS-2129 for Postsurgical Pain Management in Abdominal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 360}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-13', 'studyFirstSubmitDate': '2025-09-15', 'studyFirstSubmitQcDate': '2025-09-15', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The time-weighted sum of differences in resting pain intensity within 48 hours after the start of administration of the investigational product.', 'timeFrame': 'Within 48 hours after the start of administration of the investigational product.'}], 'secondaryOutcomes': [{'measure': 'The time-weighted sums of differences in resting pain intensity at 6 hours, 12 hours, 16 hours, 24 hours, within 12 hours-24 hours, and within 24 hours-48 hours after the start of administration (Sum of Pain Intensity Difference, SPID).', 'timeFrame': 'At 6 hours, 12 hours, 16 hours, 24 hours, within 12 hours-24 hours, and within 24 hours-48 hours after the start of administration.'}, {'measure': 'The time-weighted sums of differences in movement-related pain intensity at 6 hours, 12 hours, 16 hours, 24 hours, within 12 hours-24 hours, and within 24 hours-48 hours after the start of administration.', 'timeFrame': 'At 6 hours, 12 hours, 16 hours, 24 hours, within 12 hours-24 hours, and within 24 hours-48 hours after the start of administration.'}, {'measure': 'Proportion of subjects with a reduction of ≥30%, ≥50%, and ≥70% in resting pain Numeric Rating Scales (NRS) scores from baseline at 24 hours and 48 hours after the first dose.', 'timeFrame': 'At 24 hours and 48 hours after the first dose.'}, {'measure': 'Proportion of subjects with a reduction of ≥30%, ≥50%, and ≥70% in movement-related pain NRS scores from baseline at 24 hours and 48 hours after the first dose.', 'timeFrame': 'At 24 hours and 48 hours after the first dose.'}, {'measure': 'Percentage of subjects who did not use rescue analgesics within 0-24 hours, 24-48 hours, and 0-48 hours after the first dose.', 'timeFrame': 'Within 0-24 hours, 24-48 hours, and 0-48 hours after the first dose.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Analgesia']}, 'descriptionModule': {'briefSummary': 'This is a phase II/III, multi-center, randomized, double-blind, comparator-controlled study to evaluate the efficacy and safety of HRS-2129 for postoperative pain management in abdominal surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form before initiating trial-related activities, fully understand the purpose and significance of this trial, and voluntarily comply with the trial procedures;\n2. Scheduled to undergo abdominal surgery (laparotomy or laparoscopy) under general anesthesia;\n3. Aged ≥ 18 years (based on the date of signing the informed consent form), regardless of gender;\n4. Body Mass Index (BMI) between 18.0 kg/m² and 30.0 kg/m² (inclusive);\n5. American Society of Anesthesiologists (ASA) Physical Status Classification Grade I to II;\n6. Within 6 hours after surgery (timed from the completion of the last suture), the subject has a Resting Pain Numeric Rating Scale (NRS) score ≥ 4 at any time point;\n7. Male and female subjects of childbearing potential must agree to use effective contraceptive measures together with their partners from the time of signing the informed consent form until 1 month after the last administration of the investigational product, with no childbearing plans and no intention to donate sperm/eggs; Female subjects of childbearing potential must have a negative serum pregnancy test within 3 days before the first administration (or within 2 days before surgery) and must not be breastfeeding.\n\nExclusion Criteria:\n\n1. Subjects with a history of asthma, chronic urticaria, severe allergic reactions (see Appendix 13.11 for details), allergies to multiple (3 or more) drugs or foods, as well as a personal history or family history of hereditary angioedema before randomization;\n2. Subjects with a history of new-onset myocardial infarction or unstable angina pectoris within 6 months before randomization, or a history of New York Heart Association (NYHA) Heart Failure Classification Grade II or higher;\n3. Subjects with a history of arrhythmia requiring treatment before surgery;\n4. Subjects who developed severe arrhythmia during surgery and were deemed unsuitable for participation in this study by the investigator;\n5. Subjects with a history of malignant tumor within 5 years before randomization (except for cutaneous squamous cell carcinoma or cutaneous basal cell carcinoma that has been completely resected and is clinically stable);\n6. Subjects with a previous history of motion sickness, and the investigator judges that they may experience nausea and vomiting after surgery;\n7. Subjects with a history of mental system diseases (such as schizophrenia, depression, etc.) and cognitive impairment before randomization;\n8. Subjects with concurrent pain in various parts of the body, which the investigator believes may confuse the assessment of postoperative pain Subjects with a history of pheochromocytoma before randomization;\n9. Subjects with concurrent conditions that the investigator believes may affect pain assessment, such as skin or neurological lesions in the affected skin area that may affect sensation;\n10. Subjects with a previous surgical history at the surgical site;\n11. QTc interval at screening: \\> 450 ms for males and \\> 470 ms for females (QTc calculated using the Fridericia formula); other electrocardiographic abnormalities that are clinically significant as judged by the investigator, which may affect the subject's safety or cause distress to the subject's participation in this clinical trial;\n12. Subjects with hypertension (systolic blood pressure \\> 180 mmHg or diastolic blood pressure \\> 110 mmHg) or hypotension (systolic blood pressure \\< 90 mmHg or diastolic blood pressure \\< 60 mmHg) at screening, excluding abnormalities occurring during the period from entry into the operating room to exit from the recovery room;\n13. Subjects with laboratory test abnormalities at screening;\n14. Positive hepatitis B surface antigen (HBsAg) or positive hepatitis C virus antibody (HCV Ab) at screening (further testing for hepatitis B virus deoxyribonucleic acid (HBV DNA) titer or hepatitis C virus ribonucleic acid (HCV RNA) is required; subjects with results exceeding the detection limit of the assay must be excluded); positive human immunodeficiency virus antibody (HIV Ab); positive serum treponema pallidum antibody (TP Ab) (further testing for treponema pallidum titer is required; subjects with positive results must be excluded);\n15. Participation in any other clinical study within 3 months before randomization;\n16. Use of other drugs that affect analgesic efficacy before screening, where the time from the last dose to randomization is less than 5 times the drug's half-life;\n17. Other circumstances where the investigator judges that the subject is unsuitable for participation in this clinical trial."}, 'identificationModule': {'nctId': 'NCT07185594', 'briefTitle': 'A Phase Ⅱ/Ⅲ Study of HRS-2129 for Postsurgical Pain Management in Abdominal Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shandong Suncadia Medicine Co., Ltd.'}, 'officialTitle': 'A Phase Ⅱ/Ⅲ Study to Evaluate the Efficacy and Safety of HRS-2129 for Postsurgical Pain Management in Abdominal Surgery', 'orgStudyIdInfo': {'id': 'HRS-2129-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HRS-2129 low-dose group', 'interventionNames': ['Drug: HRS-2129 Tablets', 'Drug: Blank Preparation.']}, {'type': 'EXPERIMENTAL', 'label': 'HRS-2129 middle-dose group', 'interventionNames': ['Drug: HRS-2129 Tablets', 'Drug: Blank Preparation.']}, {'type': 'EXPERIMENTAL', 'label': 'HRS-2129 high-dose group', 'interventionNames': ['Drug: HRS-2129 Tablets', 'Drug: Blank Preparation.']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Blank preparation placebo group', 'interventionNames': ['Drug: Blank Preparation.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tramadol Hydrochloride SR Tablets group', 'interventionNames': ['Drug: Tramadol Hydrochloride SR Tablets']}], 'interventions': [{'name': 'HRS-2129 Tablets', 'type': 'DRUG', 'description': 'HRS-2129 tablets.', 'armGroupLabels': ['HRS-2129 high-dose group', 'HRS-2129 low-dose group', 'HRS-2129 middle-dose group']}, {'name': 'Blank Preparation.', 'type': 'DRUG', 'description': 'Blank preparation.', 'armGroupLabels': ['Blank preparation placebo group', 'HRS-2129 high-dose group', 'HRS-2129 low-dose group', 'HRS-2129 middle-dose group']}, {'name': 'Tramadol Hydrochloride SR Tablets', 'type': 'DRUG', 'description': 'Tramadol Hydrochloride SR tablets.', 'armGroupLabels': ['Tramadol Hydrochloride SR Tablets group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '450052', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianjun Yang', 'role': 'CONTACT', 'email': 'jianjunyang1971@163.com', 'phone': '+86-0371-67967037'}, {'name': 'Jianjun Yang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The First Affiliated Hospital of Zhengzhou University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '310009', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Min Yan', 'role': 'CONTACT', 'email': 'yanminnina@hotmail.com', 'phone': '+86-0571-87783651'}, {'name': 'Min Yan', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Second Affiliated Hospital of Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Lei Tang', 'role': 'CONTACT', 'email': 'lei.tang.lt31@hengrui.com', 'phone': '+86-0518-82342973'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong Suncadia Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}