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Tests treatment safety and results for Moderate to Severe Acute Postoperative Pain
Official title Evaluate the Safety and Efficacy of HL-1186 Tablet for Moderate to Severe Acute Pain After Surgery
ClinicalTrials.gov ID: NCT07147049
What this study is testing
What is HL-1186?
HL-1186 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for moderate to severe acute postoperative pain.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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.
You likely can't join if
- 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...
- QTcF ≥450 ms (using Fridericia correction), unstable angina, myocardial infarction, severe arrhythmias (e.g., third-degree atrioventricular block)...
- High bleeding risk conditions: Congenital bleeding disorders (e.g., hemophilia), platelet function abnormalities (e.g., idiopathic thrombocytopenic...
- For female participants: Pregnant or lactating (within 1 year postpartum).
See the full eligibility 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.
- 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...
- 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...
- High bleeding risk conditions: Congenital bleeding disorders (e.g., hemophilia), platelet function abnormalities (e.g., idiopathic thrombocytopenic purpura, disseminated intravascular coagulation, congenital platelet...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Chengdu, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chengdu, Sichuan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.