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New injection could ease pain after bone surgery

NCT ID NCT07186426

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 27, 2026 · Updated 3 times

Summary

This study tests a new drug called HSK21542 for pain after hip replacement surgery. About 405 adults will receive either HSK21542, morphine, or a placebo. The goal is to see if HSK21542 reduces pain better and causes fewer side effects like nausea and vomiting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HSK21542 injection
What this could lead to
If successful, this could provide a new option for managing pain after orthopedic surgery with potentially fewer side effects than current treatments.
What could go wrong
This is still an experimental drug. Even in Phase 3, it may not prove more effective or safer than existing painkillers like morphine. Side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

405 people

The number who actually took part.

Started

Aug 2025

Finished

Feb 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 74 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 18 years old ≤ age ≤74 years old, regardless of gender; * 18 kg/m2≤BMI≤32 kg/m2,meet the weight range specified in the protocol; * American Society of Anesthesiologists (ASA) grade ⅰ-ⅲ; * Accept hip replacement under general anesthesia; * Within 4 hours after the end of surgery, NRS≥4 in the resting state at any time; * Fully understand and voluntarily participate this trial, and sign the informed consent form; Exclusion Criteria: * Patients with allergy to opioids or any component of the trial drug; * Patients with a history of severe cardiovascular and cerebrovascular diseases, ,and psychiatric disorders; * Last use of opioid or non-opioid analgesics less than 5 half-lives or the duration of drug efficacy prior to randomization; use of drugs with unclear half-lives that may affect analgesic efficacy within 7 days prior to randomization, or last use of drugs affecting analgesic efficacy less than 5 half-lives prior to randomization, as well as Chinese herbal medicines or proprietary Chinese medicines deemed by the investigator as potentially impacting the evaluation of efficacy and safety; * Continuous use of opioid analgesics for more than 7 days for any reason within 30 days prior to screening; * Laboratory test results during the screening period meeting any of the following criteria: 1) Significantly abnormal hematology results; 2) Significantly abnormal prothrombin time test results; 3) Significantly abnormal liver or kidney function; 4) Significantly abnormal fasting blood glucose; * Positive test results during the screening period for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), syphilis antibody, or human immunodeficiency virus (HIV) antibody; * A history of drug, drug, and/or alcohol abuse; * Participate in any clinical trail within 30 days; * Pregnant or lactating female subjects; * Subjects of childbearing potential who are unwilling to use contraception throughout the study period or plan to become pregnant within 3 months after the study.; * Subjects with any other factor considered by the investigator to be ineligible for participation in the trial.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Xiangya Hospital of Central South University

    Changsha, Hunan, China

  • Xuanwu Hospital Capital Medical University

    Beijing, Beijing Municipality, China

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