A Study of SHR8554 Injection for the Treatment of Pain After Orthopedic Surgery

December 22, 2023 updated by: Jiangsu HengRui Medicine Co., Ltd.

A Phase II/Ⅲ, Randomized, Double-Blind, Dose-explored, Active-controlled Study of SHR8554 Injection for the Treatment of Pain After Orthopedic Surgery

The primary objective is to evaluate the analgesic efficacy of IV SHR8554 compared with morphine and placebo in patients with acute postoperative pain following orthopedic surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

320

Phase

  • Phase 2
  • Phase 3

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

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Shanghai Jiaotong University School of Medicine,Renji Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Able and willing to provide a written informed consent
  2. Subjects requiring elective general anesthesia orthopedic surgery
  3. Conform to the ASA Physical Status Classification

Exclusion Criteria:

  1. Subjects with a history of difficult airway
  2. Subjects with a history of reflux esophagitis
  3. Subjects with a history of mental illness
  4. Subjects with poor blood pressure control
  5. Transcutaneous oxygen saturation (SpO2) <90%
  6. Random blood glucose ≥11.1mmol/L
  7. Subjects with abnormal liver function
  8. allergies to opioids and other medications that may be used during 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
Experimental: Treatment group A：SHR8554 Injection
Drug: SHR8554 Injection
SHR8554 Injection; high dose
Drug: SHR8554 Injection
SHR8554 Injection; low dose
Experimental: Treatment group B：SHR8554 Injection
Drug: SHR8554 Injection
SHR8554 Injection; high dose
Drug: SHR8554 Injection
SHR8554 Injection; low dose
Active Comparator: Treatment group D：Morphine
Drug: Morphine
Morphine
Placebo Comparator: Treatment group C：Saline Solution
Drug: Saline Solution
Saline Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the Sum of Pain Intensity Differences in Pain Score Over 48 Hours in the rest state
Time Frame: 48-hours
Pain intensity will be evaluated using an 11-point (0-10) Numeric Pain Rating Scale (NPRS), with higher numbers indicating a higher pain intensity, administered over 48 hours. Time weighted average change from baseline is calculated using the following: time weighted sum of pain intensity differences (SPID) divided by a constant (48 hours) to yield values on the 0-10 NPRS.
48-hours

Secondary Outcome Measures

Outcome Measure
Time Frame
the Sum of Pain Intensity Differences in Pain Score Over 6、12、24、 48 、12-24、24-48 Hours under static and moving condition
Time Frame: 48-hours
48-hours
Time of first use of remedial analgesic medication
Time Frame: 48-hours
48-hours
Cumulative use of remedial analgesics from 0h to 48h
Time Frame: 48-hours
48-hours
Participant ' satisfaction score for analgesia treatment
Time Frame: 48-hours
48-hours
Investigator satisfaction score for analgesia treatment
Time Frame: 48-hours
48-hours

Collaborators and Investigators

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

Sponsor

Jiangsu HengRui Medicine 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 (Actual)

May 11, 2022

Primary Completion (Actual)

October 19, 2023

Study Completion (Actual)

October 19, 2023

Study Registration Dates

First Submitted

May 11, 2022

First Submitted That Met QC Criteria

May 11, 2022

First Posted (Actual)

May 16, 2022

Study Record Updates

Last Update Posted (Actual)

December 26, 2023

Last Update Submitted That Met QC Criteria

December 22, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHR8554-203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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