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

NCT07699601 | Recruiting Phase 2 DMC

• 1 other identifier: PY-HL-1186-OS-302
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• SPID48

  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).

  0 to 48 hours

Secondary Outcomes (1)

• Number of participants with treatment-related adverse events

  0-9 days

Study Arms (4)

HL-1186 High-Dose Group

EXPERIMENTAL

Participants will be randomized to either the HL-1186 groups, placebo group or active-comparator group, and administer study drug every 6 hours

Drug: HL-1186; Drug: Oxycodone-Acetaminophen Matching Placebo

HL-1186 Low-Dose Group

EXPERIMENTAL

Participants will be randomized to either the HL-1186 groups, placebo group or active-comparator group, and administer study drug every 6 hours

Drug: HL-1186; Drug: HL-1186 placebo; Drug: Oxycodone-Acetaminophen Matching Placebo

Oxycodone-Acetaminophen Group

ACTIVE COMPARATOR

Participants will be randomized to either the HL-1186 groups, placebo group or active-comparator group, and administer study drug every 6 hours

Drug: HL-1186 placebo; Drug: Oxycodone-Acetaminophen

Placebo Group

PLACEBO COMPARATOR

Participants will be randomized to either the HL-1186 groups, placebo group or active-comparator group, and administer study drug every 6 hours

Drug: HL-1186 placebo; Drug: Oxycodone-Acetaminophen Matching Placebo

Interventions

HL-1186 DRUG

HL-1186 tablet for oral administration.

HL-1186 High-Dose Group; HL-1186 Low-Dose Group

HL-1186 placebo DRUG

HL-1186 placebo tablet for oral administration.

HL-1186 Low-Dose Group; Oxycodone-Acetaminophen Group; Placebo Group

Oxycodone-Acetaminophen DRUG

Oxycodone-Acetaminophen for oral adminstration

Oxycodone-Acetaminophen Group

Oxycodone-Acetaminophen Matching Placebo DRUG

Oxycodone-Acetaminophen Matching Placebo for oral adminstration

HL-1186 High-Dose Group; HL-1186 Low-Dose Group; Placebo Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old ≤ age ≤ 75 years old, gender is not limited.
• 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.
• 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.

Sponsors & Collaborators

• Shanghai Huilun Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The Third Xiangya Hospital of Central South University, Changsha, Hunan

Changsha, Hunan, China

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

oxycodone-acetaminophen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

MeiXuan Li

CONTACT

021-64311017; clinical_trial@hllife.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2026
• First Posted: July 13, 2026
• Study Start: May 9, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)