A Trial of HR021618 in Postsurgical Pain Management

Study Overview
=================
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.

Official Title
-----------------
A Phase Ⅱ, Multicenter, Randomized, Single-Blind, Placebo-Controlled, Evaluation of the Safety, Efficacy of HR021618 for Pain Management Following Orthopaedic Surgery

Conditions
-----------------
Postsurgical Pain Management

Intervention / Treatment
-----------------
* Drug: HR021618
* Drug: HR021618
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: HR021618 compared with placebo
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group A<br> | Drug: HR021618<br>* Treatment group A:HR021618; high dose<br>|
| Experimental: Treatment group B<br> | Drug: HR021618<br>* Treatment group B:HR021618; low dose<br>|
| Placebo Comparator: Treatment group C<br> | Drug: Placebo<br>* Treatment group C: HR021618 blank preparation.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usage of Morphine, Post Surgery | Change in the amount of morphine use (in milligrams) by subjects in each treatment group for a 24 hour period post IP administration. | 0 hour to 24 hours after IP administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usage of Morphine, Post Surgery at other intervals | Change in the amount of morphine use (in milligrams) by subjects in each treatment group for 0-48 hours after IP administration. | 0 hour to 48 hours after IP administration | 
| Pain intensity assessed using an 11-point NRS ranging | 11-point NPRS ranging from a score of 0 to 10. | Baseline till 48 hours post IP administration | 
| Pain relief assessed using an 5-point likert scale | 5-point likert scale from a score of 0 to 4. | Baseline till 48 hours post IP administration | 
| Time to First Dose of Rescue Analgesia | Time to first rescue was calculated as the elapsed time from administration of Dose 1 to the administration of the first dose of rescue analgesia. | 0 hour to 48 hours after IP administration | 
| Frequency of Doses of Rescue Analgesia Utilized Per Subject | Rescue analgesia was available to subjects with inadequately controlled pain upon request. | 0 hour to 48 hours after IP administration | 
| Proportion of subjects who received Rescue Analgesia | Proportion of rescue was calculated as the elapsed time from administration of Dose 1 to the administration of the first dose of rescue analgesia. | 0 hour to 48 hours after IP administration | 
| Patient Global Assessment (PGA) of Pain Control | PGA of pain control was evaluated by subject reported degree of pain control according to a 5 point scale (0-4) | 0 hour to 48 hours after IP administration |