Health TrialsbyHealthPanel

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

ConditionPostoperative Pain
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

330 Participants
are divided into 4 treatment groups
Group A: HL-1186 High-Dose GroupExperimental treatment 2 interventions
Group B: HL-1186 Low-Dose GroupExperimental treatment 3 interventions
Group C: Oxycodone-Acetaminophen GroupActive comparator 2 interventions
Group D: Placebo GroupPlacebo comparator 2 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Huilun Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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