HR021618 in Moderate to Severe Pain After Abdominal Surgery

Study Overview
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Brief Summary
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The study is being conducted to evaluate the efficacy and safety of HR021618 in the treatment of moderate to severe pain after abdominal surgery.

Official Title
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A Phase Ⅱ, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of HR021618 in the Treatment of Moderate to Severe Pain After Abdominal Surgery

Conditions
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Pain After Abdominal Surgery

Intervention / Treatment
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* Drug: HR021618
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group A<br> | Drug: HR021618<br>* Treatment group A: HR021618 injection<br>|
| Placebo Comparator: Treatment group B<br> | Drug: Placebo<br>* Treatment group B: Saline injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC48 | Area under the pain intensity-time curve. | 48 hours after recovery from anesthesia] Area under the pain intensity-time curve. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total consumption of morphine over 0-48, 0-24, 24-48 hours | Total consumption of morphine after recovery from anesthesia. | 48 hours after recovery from anesthesia | 
| AUC3, AUC24, AUC15-21, AUC18-24, AUC24-28, AUC39-45, AUC42-48 | Area under the pain intensity-time curve. | 48 hours after recovery from anesthesia | 
| Time of the first dose of rescue analgesia | Time of the first dose of rescue analgesia after recovery from anesthesia. | 48 hours after recovery from anesthesia | 
| Proportion of subjects receiving rescue analgesia | Proportion of subjects receiving rescue analgesia after recovery from anesthesia. | 48 hours after recovery from anesthesia | 
| Frequency of doses of rescue analgesia | Frequency of doses of rescue analgesia after recovery from anesthesia. | 48 hours after recovery from anesthesia | 
| Subjects' satisfaction rating | Subjects' satisfaction rating. | 48 hours after recovery from anesthesia | 
| Anesthesiologist satisfaction rating | Anesthesiologist satisfaction rating. | 48 hours after recovery from anesthesia |