Evaluate the Safety and Efficacy of HL-1186 Tablet for Postoperative Analgesia in Orthopedic Surgery
Recruiting now · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Postoperative Pain
In brief
This clinical trial is a multiple-center, randomized, double-blind, placebo- and active-controlled parallel-group Phase II/III clinical trial, to evaluate the efficacy and safety of HL-1186 Tablets for Postoperative Analgesia in Orthopedic Surgery.
Key facts
- Study ID
- NCT07699601
- Run by
- Shanghai Huilun Pharmaceutical Co., Ltd.
- People needed
- 330
- Starts
- 2026-05-09
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-07-13
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 18 years old ≤ age ≤ 75 years old, gender is not limited.
- 18 kg/m2 ≤ Body Mass Index (BMI) ≤ 30kg/m2.
- Scheduled to undergo orthopedic surgery under general anesthesia, with expected moderate-to-severe postoperative pain intensity.
- Able to understand the research process and the use of pain scales, and communicate effectively with researchers.
- After surgery completion, the participant is judged by the investigator to be awake and has a resting NRS score ≥ 4.
You may not qualify if…
- Previous surgery on the same site that may affect pain perception at the surgical site.
- Paresthesia or other pain that may affect postoperative pain evaluation or scale assessment.
- Neuropsychological disorders that may affect postoperative pain evaluation or scale assessment.
- Unstable angina, myocardial infarction, severe arrhythmia, NYHA cardiac function class ≥ III, or recurrent asthma attacks, etc., deemed unsuitable for inclusion by the investigator.
- Poorly controlled hypertension.
- Sleep apnea syndrome, or the presence of a difficult airway as assessed by the investigator.
- Known allergy to any component of the investigational drug(s), to perioperative (from induction of anesthesia to completion of surgery) anesthetic/analgesic/antiemetic drugs, or a history of allergy to ≥ 3 substances.
- Positive for human immunodeficiency virus (HIV) antibody; positive for Treponema pallidum antibody and positive toluidine red unheated serum test (TRUST); positive for hepatitis B surface antigen (HBsAg) with detectable HBV-DNA; or positive for hepatitis C virus (HCV) antibody.
- Women who are pregnant or breastfeeding (within 1 year after delivery).
- Participation in another drug or medical device trial within 1 month before screening, or currently participating in another clinical trial receiving investigational intervention.
- Any other condition considered unsuitable for participation by the investigator.
Where it is running
- The Third Xiangya Hospital of Central South University, Changsha, Hunan — Changsha, Hunan, China (enrolling)
Full record on ClinicalTrials.gov
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