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Recruiting NCT07147049

Evaluate the Safety and Efficacy of HL-1186 Tablet for Moderate to Severe Acute Pain After Surgery

Phase II Interventional Moderate to Severe Acute 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.
Who it may be relevant to
Registry conditions: Moderate to Severe Acute 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 Phase 2a, Randomized, Double-blind, Placebo-controlled, Parallel Study Evaluating the Safety and Efficacy of HL-1186 Tablet for Moderate to Severe Acute Pain After Surgery

Overview

This is a multiple-center, randomized, double-blind, placebo-controlled study design evaluating the safety, efficacy, and pharmacokinetics (PK) parameter of HL-1186 tablet for moderate to severe acute pain after surgery.

Interventions

  • Drug HL-1186
    HL-1186 tablet for oral administration.
  • Drug HL-1186 placebo
    HL-1186 placebo tablet for oral administration.

Primary outcome measures

  • SPID48 [Time frame: 0 to 48 hours]
Secondary outcome measures (1)
  • Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [Time frame: Day 1 to Day 30]

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 one of the following elective surgeries under general anesthesia: Orthopedic surgery, abdominal surgery, or thoracic surgery.
  • Able to understand the research process and the use of pain scales, and communicate effectively with researchers.
  • Participant reported pain of ≥4 on the NRS.

Exclusion criteria

  • Prior history of surgery at the same site, and this may affect pain perception at the surgical site per investigator's judgments.
  • Allergy to any component of the investigational product, to perioperative anesthetic/analgesic/antiemetic agents, or to ≥3 substance allergies.
  • Use of the prohibited medications specified in the protocol within 5 half-lives of the drug (or 7 days if half-life is unknown) prior to randomization, and this may affect pain or scale assessments per investigator's judgments.
  • QTcF ≥450 ms (using Fridericia correction), unstable angina, myocardial infarction, severe arrhythmias (e.g., third-degree atrioventricular block), New York Heart Association (NYHA) class III or higher cardiac function, recurrent asthma, etc., within screen period, and deemed ineligible per investigator's judgments.
  • High bleeding risk conditions: Congenital bleeding disorders (e.g., hemophilia), platelet function abnormalities (e.g., idiopathic thrombocytopenic purpura, disseminated intravascular coagulation, congenital platelet function abnormalities), active bleeding, etc., and deemed ineligible per investigator's judgments.
  • For female participants: Pregnant or lactating (within 1 year postpartum).
  • Participants with childbearing potential planning conception/sperm/egg donation within 6 months post-treatment, or unwilling to use effective contraception (abstinence, barrier methods, oral contraceptives, intrauterine device, or sterilization).
  • Participants who have participated in other investigational product/device studies within 30 days prior to the screening visit, or are currently enrolled in another study.
  • Judgment by the investigator that the participant should not enter the study due to other conditions.

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: NCT07147049 · PY-HL-1186-IIa-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗