Status:
UNKNOWN
A Trial of HR021618 in Postsurgical Pain Management
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Postsurgical Pain Management
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The study is being conducted to evaluate the efficacy, safety of HR021618 and to explore the reasonable dosage of HR021618 for Pain Management after Orthopaedic surgery.
Eligibility Criteria
Inclusion
- Able and willing to provide a written informed consent
- Subjects requiring elective Orthopaedic surgery
- Male or female
- Meet the weight standard
- Conform to the ASA Physical Status Classification Postoperative randomization criteria Exclusion Criteria
- 1、 Sufficient pain to require IVanalgesia assessed by NRS ranging 2、 No evidence of organ insufficiency, or any other abnormality, during or following surgery
Exclusion
- History of major surgery
- History of active or high-risk bleeding disorders
- History of myocardial infarction or coronary artery bypass
- History or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, or other condition that would preclude participation in the study
- Abnormal values in the laboratory
- Have a known allergy to meloxicam or any excipient of HR021618, , aspirin, other non-steroidal anti-inflammatory drugs (NSAIDs) or to any peri- or postoperative medications used in this 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
- Planned/actual admission to the intensive care unit
- Pregnant or nursing women
- No birth control during the specified period of time
- Participated in clinical trials of other drugs (received experimental drugs)
- The inestigators determined that other conditions were inappropriate for participation in this clinical trial
Key Trial Info
Start Date :
December 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 8 2021
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT04699175
Start Date
December 17 2020
End Date
August 8 2021
Last Update
August 6 2021
Active Locations (1)
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1
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, China, 200433