Recruiting
Phase 2
Evaluate the Safety and Efficacy of HL-1186 Tablet for Postoperative Pain Management in Abdominal Surgery
Condition(s) studied
Moderate to Severe Acute Postoperative Pain
Investigational drug(s) / intervention(s)
HL-1186: HL-1186 tablet for oral administration.
HL-1186 placebo: HL-1186 placebo tablet for oral administration.
Study 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.
Eligibility
Inclusion Criteria:
1. 18 years old ≤ age ≤ 75 years old, gender is not limited.
2. 18 kg/m2 ≤ Body Mass Index (BMI) ≤ 30kg/m2.
3. Scheduled to undergo abdominal surgeries under general anesthesia.
4. Able to understand the research process and the use of pain scales, and communicate effectively with researchers.
Exclusion Criteria:
1. Prior history of surgery at the same site, and this may affect pain perception at the surgical site per investigator's judgments.
2. Allergy to any component of the investigational product, to perioperative anesthetic/analgesic/antiemetic agents, or to ≥3 substance allergies.
3. 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.
4. 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.
5. For female participants: Pregnant or lactating (within 1 year postpartum).
6. 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).
7. Judgment by the investigator that the participant should not enter the study due to other conditions.
Primary outcome measure(s)
- SPID48 — 0 to 48 hours
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).
Trial sites (1)
| Facility | City | Region | Status |
| The Third Xiangya Hospital of Central South University |
Changsha |
Hunan |
Recruiting |
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