A Trial of SHR0410 Injection for the Treatment of Pain After Laparoscopic Surgery

A Phase Ⅲ, Randomized, Double-blind, Placebo-controlled Study of SHR0410 Injection for the Treatment of Pain After Laparoscopic Surgery

The study is being conducted to evaluate the efficacy and safety of SHR0410 injection for the treatment of pain after laparoscopic surgery

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Pain Of Laparoscopic Surgery
• Intervention / Treatment: Drug: SHR0410 Injection; Drug: SHR0410 Injection; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 357
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Qin Liu; Phone Number: +0518-82342973; Email: qin.liu@hengrui.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 endoscopic surgery of the lower abdominal
3. Male or female
4. Meet the body mass index standard
5. Conform to the ASA Physical Status Classification

Exclusion Criteria:

1. Subjects with a history of difficult airway
2. Subjects with a history of mental illness
3. Subjects with a history of cognitive impairment epilepsy
4. Subjects with a history of myocardial infarction or unstable angina pectoris
5. Subjects with atrioventricular block or cardiac insufficiency
6. Subjects with a history of ischemic stroke or transient ischemic attack
7. Subjects with poor blood pressure control after medication
8. Subject with a history of substance abuse and drug abuse
9. Abnormal values in liver function
10. Allergic to drugs that may be used during the study
11. Pregnant or nursing women
12. No birth control during the specified period of time
13. Participated in clinical trials of other drugs (received experimental drugs)
14. The investigators determined that other conditions were 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: Treatment group A; SHR0410 Injection（Low Dose）	Drug: SHR0410 Injection; SHR0410 Injection（Low Dose）; Drug: SHR0410 Injection; SHR0410 Injection（High Dose）
Experimental: Treatment group B; SHR0410 Injection（High Dose）	Drug: SHR0410 Injection; SHR0410 Injection（Low Dose）; Drug: SHR0410 Injection; SHR0410 Injection（High Dose）
Placebo Comparator: Treatment group C; Placebo for SHR0410 Injection.	Drug: Placebo; Placebo for SHR0410 Injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Summed Pain Intensity Difference From 0-24 Hours (SPID0-24)	Pain intensity will be evaluated using an 11-point (0-10) numeric rating scale (NRS), with higher numbers indicating a higher pain intensity.	0 to 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Summed Pain Intensity Difference Within The First 2 Hours、4 Hours、6 Hours、12 Hours、18 Hours (SPID2、SPID4、SPID6、 SPID12、SPID18)	Pain intensity will be evaluated using an 11-point (0-10) numeric rating scale (NRS), with higher numbers indicating a higher pain intensity.	0 to 2 hours、0 to 4 hours、0 to 6 hours、0 to 12 hours、0 to 18 hours
Estimated Time From The Start Of The Infusion Of Study Drug To The First NRS reaching 3 or less		0 to 24 hours
Total Pain Relief Within The First 2 Hours、4 Hours、6 Hours、12 Hours、18 Hours、24 Hours	Patients reported their pain relief using a 5-point(0-4) categorical scale (PR), with "0" indicating "No Relief", "1" indicating "A Little Relief", "2" indicating "Some Relief ", "3" indicating "A Lot of Relief" and "4" indicating "Complete Relief".	0 to 2 hours、0 to 4 hours、0 to 6 hours、0 to 12 hours、0 to 18 hours、0 to 24 hours
Total consumption of remedial analgesics from 0 to 24 hours		24-hours
Participant' Satisfaction Score For Analgesia Treatment		24-hours
Investigator Satisfaction Score For Analgesia Treatment		24-hours
Numbers of Participants With Abnormal Vital Signs	Changes in vital signs such as body temperature (using the celsius system) will be assessed at specified times.	Day 3 or Day 4
Numbers of Participants With Abnormal Vital Signs	Changes in vital signs such as, blood pressure (using mmHg) will be assessed at specified times.	Day 3 or Day 4
Numbers of Participants With Abnormal Vital Signs	Changes in vital signs such as , heart rate (measured by beats per minute) will be assessed at specified times.	Day 3 or Day 4
Numbers of Participants With Abnormal Laboratory Values	Participants with clinically significant lab values will be compared to those receiving placebo comparator.	Day 3 or Day 4

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2022
• Primary Completion (Anticipated): February 28, 2023
• Study Completion (Anticipated): February 28, 2023

Study Registration Dates

• First Submitted: June 30, 2022
• First Submitted That Met QC Criteria: July 12, 2022
• First Posted (Actual): July 14, 2022

Study Record Updates

• Last Update Posted (Actual): July 14, 2022
• Last Update Submitted That Met QC Criteria: July 12, 2022
• Last Verified: June 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: SHR0410-302

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