Status:
UNKNOWN
A Clinical Study of SHR8554 Injection for the Treatment of Pain After Orthopedic Surgery
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Pain
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
Brief Summary
The primary objective is to evaluate the analgesic efficacy of IV SHR8554 compared with placebo and morphine 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
- Pregnant or nursing women
Key Trial Info
Start Date :
April 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2021
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT04794738
Start Date
April 18 2021
End Date
October 30 2021
Last Update
August 12 2021
Active Locations (1)
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1
Shanghai Jiaotong University School of Medicine,Renji Hospital
Shanghai, Shanghai Municipality, China, 200127