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

NCT ID: NCT05375305

Last Updated: 2023-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-11

Study Completion Date

2023-10-19

Brief Summary

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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.

Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment group A：SHR8554 Injection

Group Type EXPERIMENTAL

SHR8554 Injection

Intervention Type DRUG

SHR8554 Injection; high dose

Treatment group B：SHR8554 Injection

Group Type EXPERIMENTAL

SHR8554 Injection

Intervention Type DRUG

SHR8554 Injection; low dose

Treatment group C：Saline Solution

Group Type PLACEBO_COMPARATOR

Saline Solution

Intervention Type DRUG

Saline Solution

Treatment group D：Morphine

Group Type ACTIVE_COMPARATOR

Morphine

Intervention Type DRUG

Morphine

Interventions

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SHR8554 Injection

SHR8554 Injection; high dose

Intervention Type DRUG

SHR8554 Injection

SHR8554 Injection; low dose

Intervention Type DRUG

Saline Solution

Saline Solution

Intervention Type DRUG

Morphine

Morphine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shanghai Jiaotong University School of Medicine,Renji Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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SHR8554-203

Identifier Type: -

Identifier Source: org_study_id