Status:
COMPLETED
A Clinical Study of SHR8554 Injection for the Treatment of Pain After Abdominal Surgery.
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Pain
Eligibility:
All Genders
18-65 years
Phase:
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 abdominal surgery
Eligibility Criteria
Inclusion
- Able and willing to provide a written informed consent
- Subjects requiring elective general anesthesia abdominal 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 :
March 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2021
Estimated Enrollment :
528 Patients enrolled
Trial Details
Trial ID
NCT04766463
Start Date
March 3 2021
End Date
November 1 2021
Last Update
July 6 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Union Hospital Affiliated to Tongji Medical Collage Huazhong University of Science and Technology
Wuhan, Wuhan, China, 430021