Status:
COMPLETED
A Study of SHR8554 Injection for the Treatment of Pain After Orthopedic Surgery
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- Able and willing to provide a written informed consent
- Subjects requiring elective general anesthesia orthopedic surgery
- Conform to the ASA Physical Status Classification
Exclusion
- Subjects with a history of difficult airway
- Subjects with a history of reflux esophagitis
- Subjects with a history of mental illness
- Subjects with poor blood pressure control
- Transcutaneous oxygen saturation (SpO2) \<90%
- Random blood glucose ≥11.1mmol/L
- Subjects with abnormal liver function
- allergies to opioids and other medications that may be used during the trial
Key Trial Info
Start Date :
May 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 19 2023
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT05375305
Start Date
May 11 2022
End Date
October 19 2023
Last Update
December 26 2023
Active Locations (1)
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1
Shanghai Jiaotong University School of Medicine,Renji Hospital
Shanghai, Shanghai Municipality, China, 200127