A Trial of SHR0410 Injection in Postsurgical Pain Management

A Phase Ⅱ, Randomized, Double-blind, Placebo-controlled ， Evaluation of the Safety, Efficacy of SHR0410 Injection for Pain Management Following Orthopaedic Surgery

The study is being conducted to evaluate the efficacy, safety of SHR0410 Injection and to explore the reasonable of SHR0410 Injection for Pain Management after Orthopaedic Surgery.

Study Overview

• Status: Recruiting
• Conditions: Postsurgical Pain
• Intervention / Treatment: Drug: SHR0410 Injection; Drug: Placebo for SHR0410 Injection

• Study Type: Interventional
• Enrollment (Anticipated): 108
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Qin Lin, M.M; Phone Number: +0518-82342973; Email: Qin.liu@hengrui.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Recruiting
      • Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
      • Contact: Xiangdong Chen, Doctor; Phone Number: 027-85351618; Email: Xiangdongchen2013@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Able and willing to provide a written informed consent；
2. Subjects requiring elective general anesthesia orthopedic surgery；
3. Male or female；
4. Meet the body mass index standard；
5. Conform to the ASA Physical Status Classification；
6. Negative pregnancy test.

Exclusion Criteria:

1. Subjects with a history of myocardial infarction or unstable angina pectoris；
2. Subjects with atrioventricular block or cardiac insufficiency；
3. Subjects with a history of malignancy ；
4. Subjects with a history of stroke；
5. Subjects with a history of mental illness；
6. Subjects with a history of difficult airway；
7. Random blood glucose ≥11.1mmol/L；
8. Subjects with poor blood pressure control；
9. Abnormal values in liver or renal function；
10. Subject with a history of substance abuse and drug abuse；
11. Allergic to drugs that may be used during the study；
12. 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；
13. Participated in clinical trials of other drugs (received experimental drugs)；
14. Other circumstances that the investigator judged inappropriate for participation in this clinical trial.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR0410 Injection High dose	Drug: SHR0410 Injection; SHR0410 Injection
Experimental: SHR0410 Injection Low dose	Drug: SHR0410 Injection; SHR0410 Injection
Placebo Comparator: Placebo for SHR0410 Injection	Drug: Placebo for SHR0410 Injection; SHR0410 Injection blank preparation

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 48 hour period post IP administration	0 hour to 48 hours after IP administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Usage of Morphine, Post Surgery at other intervals	Change in the amount of morphine use (in milligrams) by subjects in each treatment group for 0-24 hours after IP administration.Change in the amount of morphine use (in milligrams) by subjects in each treatment group for 4-48 hours after IP administration.	0 hour to 24 hours after IP administration ；24 hours to 48 hours after IP administration
the Sum of Pain Intensity Differences in Pain Score Over 6、12、24、48 、12-24、24-48 Hours under static condition	Pain intensity will be evaluated using an 11-point (0-10) Numeric Rating Scale (NRS), with higher numbers indicating a higher pain intensity, administered over 48 hours. Time weighted average change from baseline is calculated using the following: time weighted sum of pain intensity differences (SPID) divided by a constant (48 hours) to yield values on the 0-10 NRS.	48-hours
the Sum of Pain Intensity Differences in Pain Score Over 6、12、24、48 、12-24、24-48 Hours under moving condition	Pain intensity will be evaluated using an 11-point (0-10) Numeric Rating Scale (NRS), with higher numbers indicating a higher pain intensity, administered over 48 hours. Time weighted average change from baseline is calculated using the following: time weighted sum of pain intensity differences (SPID) divided by a constant (48 hours) to yield values on the 0-10 NRS.	48-hours
Frequency of Doses of Rescue Analgesia Utilized Per Subject， total consumption of morphine Rescue Analgesia Utilized Per Subject	Rescue analgesia was available to subjects with inadequately controlled pain upon request.	0 hour to 24 hours after IP administration ；24 hours to 48 hours after IP administration ；0 hour to 48 hours after IP administration
Total press times of PCA pump and effective press times of PCA pump	Read and record the press times and effective press times from PCA	0 hour to 24 hours after IP administration ；24 hours to 48 hours after IP administration ；0 hour to 48 hours after IP administration
Proportion of subjects who did not receive 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 24 hours after IP administration ；24 hours to 48 hours after IP administration ；0 hour to 48 hours after IP administration
Participant ' satisfaction score for analgesia treatment	Participants recalled the postoperative analgesia effect and rated their satisfaction on a scale of 0 to 10, with 0 representing dissatisfied and 10 representing very satisfied.	48-hours
Investigator satisfaction score for analgesia treatment	Postoperative analgesia was evaluated by investigators. The scale ranges from 0 to 10, with 0 being dissatisfied and 10 being very satisfied	48-hours

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2022
• Primary Completion (Anticipated): October 31, 2022
• Study Completion (Anticipated): November 3, 2022

Study Registration Dates

• First Submitted: May 24, 2022
• First Submitted That Met QC Criteria: May 24, 2022
• First Posted (Actual): May 27, 2022

Study Record Updates

• Last Update Posted (Actual): August 22, 2022
• Last Update Submitted That Met QC Criteria: August 19, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: SHR0410-202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No