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

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Huilun Pharmaceutical Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • HL-1186
  • HL-1186 placebo
  • Oxycodone-Acetaminophen
  • Oxycodone-Acetaminophen Matching Placebo

Treatment groups

330 Participants
are divided into 4 treatment groups