Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 2:41 AM
Study NCT ID:
NCT07311369
Status:
RECRUITING
Last Update Posted:
2025-12-30
First Post:
2025-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate the Safety and Efficacy of HL-1186 Tablet for Postoperative Pain Management in Abdominal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2025-12-16', 'studyFirstSubmitQcDate': '2025-12-16', 'lastUpdatePostDateStruct': {'date': '2025-12-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SPID48', 'timeFrame': '0 to 48 hours', 'description': 'SPID48: Time-weighted Sum of the Pain Intensity Difference (SPID) as recorded on an NRS (Numeric Rating Scale, 0 =no pain to 10 =worst possible pain) at rest 0 to 48 hours after the first dose of study drug. The score range was -480 (worst score) to 480 (best score).'}], 'secondaryOutcomes': [{'measure': 'Number of participants with treatment-related adverse events as assessed by CTCAE v5.0', 'timeFrame': 'Day 1 to Day 30'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Moderate to Severe Acute Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'This is a multiple-center, randomized, double-blind, placebo-controlled study design evaluating the safety, efficacy, and pharmacokinetics (PK) parameter of HL-1186 tablet for postoperative pain management in abdominal surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. 18 years old ≤ age ≤ 75 years old, gender is not limited.\n2. 18 kg/m2 ≤ Body Mass Index (BMI) ≤ 30kg/m2.\n3. Scheduled to undergo abdominal surgeries under general anesthesia.\n4. Able to understand the research process and the use of pain scales, and communicate effectively with researchers.\n\nExclusion Criteria:\n\n1. Prior history of surgery at the same site, and this may affect pain perception at the surgical site per investigator's judgments.\n2. Allergy to any component of the investigational product, to perioperative anesthetic/analgesic/antiemetic agents, or to ≥3 substance allergies.\n3. Unstable angina, myocardial infarction, severe arrhythmias (e.g., third-degree atrioventricular block), New York Heart Association (NYHA) class III or higher cardiac function, recurrent asthma, etc., within screen period, and deemed ineligible per investigator's judgments.\n4. High bleeding risk conditions: Congenital bleeding disorders (e.g., hemophilia), platelet function abnormalities (e.g., idiopathic thrombocytopenic purpura, disseminated intravascular coagulation, congenital platelet function abnormalities), active bleeding, etc., and deemed ineligible per investigator's judgments.\n5. For female participants: Pregnant or lactating (within 1 year postpartum).\n6. Participants with childbearing potential planning conception/sperm/egg donation within 6 months post-treatment, or unwilling to use effective contraception (abstinence, barrier methods, oral contraceptives, intrauterine device, or sterilization).\n7. Judgment by the investigator that the participant should not enter the study due to other conditions."}, 'identificationModule': {'nctId': 'NCT07311369', 'briefTitle': 'Evaluate the Safety and Efficacy of HL-1186 Tablet for Postoperative Pain Management in Abdominal Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Huilun Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase Ⅱa Study to Evaluate the Safety and Efficacy of HL-1186 Tablets for Postoperative Pain Management in Abdominal Surgery', 'orgStudyIdInfo': {'id': 'PY-HL-1186-AS-Ⅱa-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HL-1186', 'description': 'Participants will be randomized to either the HL-1186 group or placebo group, and administer study drug every 12 hours for 4 consecutive doses', 'interventionNames': ['Drug: HL-1186']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'HL-1186 placebo', 'description': 'Participants will be randomized to either the HL-1186 group or placebo group, and administer study drug every 12 hours for 4 consecutive doses', 'interventionNames': ['Drug: HL-1186 placebo']}], 'interventions': [{'name': 'HL-1186', 'type': 'DRUG', 'description': 'HL-1186 tablet for oral administration.', 'armGroupLabels': ['HL-1186']}, {'name': 'HL-1186 placebo', 'type': 'DRUG', 'description': 'HL-1186 placebo tablet for oral administration.', 'armGroupLabels': ['HL-1186 placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'The Third Xiangya Hospital of Central South University', 'role': 'CONTACT', 'email': 'xy3irb@163.com', 'phone': '+86-0731-88618938'}], 'facility': 'The Third Xiangya Hospital of Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'centralContacts': [{'name': 'Renhai Yang', 'role': 'CONTACT', 'email': 'clinical_trial@hllife.com.cn', 'phone': '021-64311017'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}