HL-1186 Tablet for postoperative pain after orthopedic surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, double-blind study that compares HL-1186 tablets with placebo and with oxycodone-acetaminophen for postoperative analgesia following orthopedic procedures. It includes Phase II and Phase III components to assess safety and efficacy in adults with moderate-to-severe pain after surgery. Participants are adults aged 18 to 75 with BMI between 18 and 30 kg/m2, undergoing surgery under general anesthesia, and with a resting pain score of at least 4 after surgery. The trial uses parallel groups and standardized pain scales to evaluate outcomes, with nine potential arms including HL-1186, placebo, and active comparator.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 18 years old ≤ age ≤ 75 years old, gender is not limited.
2. 18 kg/m2 ≤ Body Mass Index (BMI) ≤ 30kg/m2.
3. Scheduled to undergo orthopedic surgery under general anesthesia, with expected moderate-to-severe postoperative pain intensity.
4. Able to understand the research process and the use of pain scales, and communicate effectively with researchers.
5. After surgery completion, the participant is judged by the investigator to be awake and has a resting NRS score ≥ 4.

Exclusion Criteria:

1. Previous surgery on the same site that may affect pain perception at the surgical site.
2. Paresthesia or other pain that may affect postoperative pain evaluation or scale assessment.
3. Neuropsychological disorders that may affect postoperative pain evaluation or scale assessment.
4. Unstable angina, myocardial infarction, severe arrhythmia, NYHA cardiac function class ≥ III, or recurrent asthma attacks, etc., deemed unsuitable for inclusion by the investigator.
5. Poorly controlled hypertension.
6. Sleep apnea syndrome, or the presence of a difficult airway as assessed by the investigator.
7. 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.
8. 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.
9. Women who are pregnant or breastfeeding (within 1 year after delivery).
10. Participation in another drug or medical device trial within 1 month before screening, or currently participating in another clinical trial receiving investigational intervention.
11. Any other condition considered unsuitable for participation by the investigator.

Where it's running

• The Third Xiangya Hospital of Central South University, Changsha, Hunan
  Changsha, Hunan, China Recruiting

Study contacts

• Study coordinator: MeiXuan Li
• Email: clinical_trial@hllife.com.cn
• Phone: 021-64311017

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.