Evaluate the Safety and Efficacy of HL-1186 Tablet for Postoperative Pain Management in Abdominal… (NCT07311369) | Clinical Trial Compass
RecruitingPhase 2
Evaluate the Safety and Efficacy of HL-1186 Tablet for Postoperative Pain Management in Abdominal Surgery
China40 participantsStarted 2025-12
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 18 years old ≤ age ≤ 75 years old, gender is not limited.
✓. 18 kg/m2 ≤ Body Mass Index (BMI) ≤ 30kg/m2.
✓. Scheduled to undergo abdominal surgeries under general anesthesia.
✓. Able to understand the research process and the use of pain scales, and communicate effectively with researchers.
Exclusion criteria
✕. Prior history of surgery at the same site, and this may affect pain perception at the surgical site per investigator's judgments.
✕. Allergy to any component of the investigational product, to perioperative anesthetic/analgesic/antiemetic agents, or to ≥3 substance allergies.
✕. 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.
✕. 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.
✕. For female participants: Pregnant or lactating (within 1 year postpartum).
✕. 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).
What they're measuring
1
SPID48
Timeframe: 0 to 48 hours
Trial details
NCT IDNCT07311369
SponsorShanghai Yidian Pharmaceutical Technology Development Co., Ltd.