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Recruiting NCT07709598

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

Phase II / Phase III Interventional Postoperative Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HL-1186, HL-1186 placebo, Oxycodone-Acetaminophen, Oxycodone-Acetaminophen Matching Placebo.
Who it may be relevant to
Registry conditions: Postoperative Pain. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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 Abdominal Surgery

Overview

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 Abdominal Surgery.

Interventions

  • Drug HL-1186
    HL-1186 tablet for oral administration.
  • Drug HL-1186 placebo
    HL-1186 placebo tablet for oral administration.
  • Drug Oxycodone-Acetaminophen
    Oxycodone-Acetaminophen for oral adminstration.
  • Drug Oxycodone-Acetaminophen Matching Placebo
    Oxycodone-Acetaminophen Matching Placebo for oral adminstration.

Primary outcome measures

  • SPID48 [Time frame: 0 to 48 hours]
Secondary outcome measures (1)
  • Number of participants with treatment-related adverse events [Time frame: 0-9 days]

Eligibility criteria

Inclusion criteria

  • 18 years old ≤ age ≤ 75 years old, gender is not limited.
  • 18 kg/m2 ≤ Body Mass Index (BMI) ≤ 30kg/m2.
  • Scheduled to undergo abdominal 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.

Exclusion criteria

  • 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.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Sichuan Provincial People's Hospital — Chengdu

Identifiers

NCT: NCT07709598 · PY-HL-1186-AS-301

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗