Status:
COMPLETED
HR021618 in Moderate to Severe Pain After Abdominal Surgery
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Pain After Abdominal Surgery
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The study is being conducted to evaluate the efficacy and safety of HR021618 in the treatment of moderate to severe pain after abdominal surgery.
Eligibility Criteria
Inclusion
- Able and willing to provide a written informed consent
- Subjects requiring elective general anesthesia abdominal surgery
- Male or female
- Meet BMI standard
- Conform to the ASA Physical Status Classification
Exclusion
- Subjects with a history of abdominal surgery
- Subjects had hemorrhagic disorders
- Subjects had cardiac, serious hepatic or renal, cardiovascular or cerebrovascular, metabolic, psychiatric disorders, chronic pain, or malignant tumors
- Subjects with poor blood pressure control after medication
- Abnormal QTc
- Abnormal random blood glucose
- Abnormal values in the laboratory
- Allergic 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
- 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 :
April 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04811053
Start Date
April 12 2021
End Date
July 15 2021
Last Update
May 15 2025
Active Locations (1)
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1
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041