Evaluate the Safety and Efficacy of HL-1186 Tablet for Postoperative Analgesia in Orthopedic Surgery

NCT07699601 — Phase 2 / Phase 3, Recruiting, 330 participants, Shanghai Huilun Pharmaceutical Co., Ltd.

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A Multicenter, 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

Registry	NCT07699601
Status	Recruiting
Phase	Phase 2 / Phase 3
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	330 (Estimated)
Sponsor	Shanghai Huilun Pharmaceutical Co., Ltd. (Industry)
Conditions	Postoperative Pain
Interventions	HL-1186, HL-1186 placebo, Oxycodone-Acetaminophen, Oxycodone-Acetaminophen Matching Placebo (Drug)
Dates	start 2026-05-09, primary completion 2026-10-01 (estimated), completion 2026-12-01 (estimated), first posted 2026-07-13, last updated 2026-07-13
Locations	1 site in China

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
HL-1186 High-Dose Group	Experimental	Drug: HL-1186; Drug: Oxycodone-Acetaminophen Matching Placebo	Participants will be randomized to either the HL-1186 groups, placebo group or active-comparator group, and administer study drug every 6 hours
HL-1186 Low-Dose Group	Experimental	Drug: HL-1186; Drug: HL-1186 placebo; Drug: Oxycodone-Acetaminophen Matching Placebo	Participants will be randomized to either the HL-1186 groups, placebo group or active-comparator group, and administer study drug every 6 hours
Oxycodone-Acetaminophen Group	Active comparator	Drug: HL-1186 placebo; Drug: Oxycodone-Acetaminophen	Participants will be randomized to either the HL-1186 groups, placebo group or active-comparator group, and administer study drug every 6 hours
Placebo Group	Placebo comparator	Drug: HL-1186 placebo; Drug: Oxycodone-Acetaminophen Matching Placebo	Participants will be randomized to either the HL-1186 groups, placebo group or active-comparator group, and administer study drug every 6 hours

HL-1186 (Drug): HL-1186 tablet for oral administration.
HL-1186 placebo (Drug): HL-1186 placebo tablet for oral administration.
Oxycodone-Acetaminophen (Drug): Oxycodone-Acetaminophen for oral adminstration
Oxycodone-Acetaminophen Matching Placebo (Drug): Oxycodone-Acetaminophen Matching Placebo for oral adminstration

+Outcome measures

Primary outcomes

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).

Secondary outcomes

Number of participants with treatment-related adverse events [0-9 days]

+Eligibility

Sex: All, ages: 18 Years to 75 Years

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 orthopedic surgery under general anesthesia, with expected moderate-to-severe postoperative pain intensity.
4. Able to understand the research process and the use of pain scales, and communicate effectively with researchers.
5. After surgery completion, the participant is judged by the investigator to be awake and has a resting NRS score ≥ 4.

Exclusion Criteria:

1. Previous surgery on the same site that may affect pain perception at the surgical site.
2. Paresthesia or other pain that may affect postoperative pain evaluation or scale assessment.
3. Neuropsychological disorders that may affect postoperative pain evaluation or scale assessment.
4. Unstable angina, myocardial infarction, severe arrhythmia, NYHA cardiac function class ≥ III, or recurrent asthma attacks, etc., deemed unsuitable for inclusion by the investigator.
5. Poorly controlled hypertension.
6. Sleep apnea syndrome, or the presence of a difficult airway as assessed by the investigator.
7. 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.
8. 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.
9. Women who are pregnant or breastfeeding (within 1 year after delivery).
10. Participation in another drug or medical device trial within 1 month before screening, or currently participating in another clinical trial receiving investigational intervention.
11. Any other condition considered unsuitable for participation by the investigator.

+Locations (1)

Facility	City	Country	Status
The Third Xiangya Hospital of Central South University, Changsha, Hunan	Changsha, Hunan	China	Recruiting