Status:
TERMINATED
A Trial of SHR0410 Injection in Postsurgical Pain Management
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Postsurgical Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The study is being conducted to evaluate the efficacy, safety of SHR0410 Injection and to explore the reasonable of SHR0410 Injection for Pain Management after Orthopaedic Surgery.
Eligibility Criteria
Inclusion
- Able and willing to provide a written informed consent；
- Subjects requiring elective general anesthesia orthopedic surgery；
- Male or female；
- Meet the body mass index standard；
- Conform to the ASA Physical Status Classification；
- Negative pregnancy test.
Exclusion
- Subjects with a history of myocardial infarction or unstable angina pectoris；
- Subjects with atrioventricular block or cardiac insufficiency；
- Subjects with a history of malignancy ；
- Subjects with a history of stroke；
- Subjects with a history of mental illness；
- Subjects with a history of difficult airway；
- Random blood glucose ≥11.1mmol/L；
- Subjects with poor blood pressure control；
- Abnormal values in liver or renal function；
- Subject with a history of substance abuse and drug abuse；
- Allergic to drugs that may be used during the study；
- Use other drugs that affect the analgesic effect before randomization, and the time from the last use to randomization is shorter than 5 half-lives；
- Participated in clinical trials of other drugs (received experimental drugs)；
- Other circumstances that the investigator judged inappropriate for participation in this clinical trial.
Key Trial Info
Start Date :
August 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2023
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT05394402
Start Date
August 9 2022
End Date
May 31 2023
Last Update
June 22 2025
Active Locations (1)
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1
Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022