A Trial of SHR0410 Injection in Postsurgical Pain Management

Postsurgical Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05394402
• Other study ID #: SHR0410-202
• Status: Recruiting
• Phase: Phase 2
• Start date: August 9, 2022
• Est. completion date: November 3, 2022

Study information

• Verified date: August 2022
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Qin Lin, M.M
• Phone: +0518-82342973
• Email: Qin.liu[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: November 3, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postsurgical Pain

Intervention

Drug:
• SHR0410 Injection
SHR0410 Injection
• Placebo for SHR0410 Injection
SHR0410 Injection blank preparation

Locations

Country	Name	City	State
China	Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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