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RecruitingNCT07699601Updated Jul 13, 2026

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

A Phase 2/3 interventional study of HL-1186 and HL-1186 placebo in Postoperative Pain, sponsored by Shanghai Huilun Pharmaceutical Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-13.

Sponsored by Shanghai Huilun Pharmaceutical Co., Ltd. · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Started May 2026; still recruiting 4 months later.
Phase
Phase 2/3
Study type
Interventional
Enrollment
330
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Postoperative Pain

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03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's planned enrollment of 330 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Shanghai Huilun Pharmaceutical Co., Ltd. is the lead sponsor of 5 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
330 participants (estimated)

Study arms

  • Experimental
    HL-1186 High-Dose Group

    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

  • Experimental
    HL-1186 Low-Dose Group

    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

  • Active comparator
    Oxycodone-Acetaminophen Group

    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 comparator
    Placebo Group

    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

  • DrugHL-1186

    HL-1186 tablet for oral administration.

  • DrugHL-1186 placebo

    HL-1186 placebo tablet for oral administration.

  • DrugOxycodone-Acetaminophen

    Oxycodone-Acetaminophen for oral adminstration

  • DrugOxycodone-Acetaminophen Matching Placebo

    Oxycodone-Acetaminophen Matching Placebo for oral adminstration

06

What researchers measure

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).

    Time frame: 0 to 48 hours

Secondary outcomes

  1. Number of participants with treatment-related adverse events

    Time frame: 0-9 days

07

Study locations

1 of 1 sites recruiting
  • The Third Xiangya Hospital of Central South University, Changsha, Hunan
    Changsha, Hunan, China
    • The Third Xiangya Hospital of Central South University · Contact · xy3irb@163.com · +86-0731-88618938
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07699601
Lead sponsor
Shanghai Huilun Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Jul 13, 2026
Start date
May 9, 2026
Primary completion
Oct 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Jul 13, 2026

Study contacts

MeiXuan Li
Contact
clinical_trial@hllife.com.cn
021-64311017

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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