A Clinical Trial Evaluating the Efficacy and Safety of HSK55718 in Patients for Postoperative Pain Treatment in Orthopedic Surgery

April 20, 2026 updated by: Haisco Pharmaceutical Group Co., Ltd.

A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of HSK55718 Injection for Postoperative Pain Treatment in Orthopedic Surgery

This is a multi-center, randomized, double-blind, placebo/active-controlled study. 200 subjects undergoing orthopedic surgery under general anesthesia are planned to be enrolled and randomized into the HSK55718 group, morphine group, and placebo group.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Age ≥18 years old, regardless of gender; 18 kg/m2≤BMI≤30 kg/m2; American Society of Anesthesiologists (ASA) gradeⅰ-ⅲ; Accept abdominal surgery 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:

A history of cardiovascular, respiratory, neurological, or psychiatric diseases that meet the protocol-defined exclusion criteria.

Clinically significant abnormalities in laboratory tests during the screening period.

A history of severe drug allergy or known allergy to the investigational drug. Continuous use of opioid analgesics for more than 10 days for any reason within 3 months prior to randomization.

Use of any medication that may affect analgesia, where the last dose was administered less than 5 half-lives of that drug before randomization.

A history of drug abuse, substance abuse, and/or alcohol abuse within the past year.

Pregnant or lactating women. Participation in another drug clinical trial within 3 months prior to the screening period.

Presence of any sensory dysfunction. Presence of any painful physical condition. Subjects with any other factor considered by the investigator to be ineligible for participation in the trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: morphine
Drug: morphine
Patients administrated with morphine
Placebo Comparator: Placebo control
Drug: placebo
Patients administrated with placebo
Experimental: HSK55718 dose level1
Drug: HSK55718 dose level 1
Patients administrated with HSK55718 at dose level 1
Experimental: HSK55718 dose level 2
Drug: HSK55718 dose level 2
Patients administrated with HSK55718 at dose level 2
Experimental: HSK55718 dose level 3
Drug: HSK55718 dose level 3
Patients administrated with HSK55718 at dose level 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sum of Pain Intensity Differences (SPID)
Time Frame: 48hours
48hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of times rescue analgesic medications were administered.
Time Frame: 48 hours
48 hours
Time to Pain Relief
Time Frame: 0-48 hours
0-48 hours
Postoperative Analgesia Satisfaction Score
Time Frame: 48 hours
48 hours
Sum of Pain Intensity Differences (SPID) in other time frame
Time Frame: 0-12 hours, 12-24 hours, 24 hours, 24-48 hours
0-12 hours, 12-24 hours, 24 hours, 24-48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haisco Pharmaceutical Group Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

April 20, 2026

First Submitted That Met QC Criteria

April 20, 2026

First Posted (Actual)

April 27, 2026

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSK55718-202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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