A Trial of SHR0410 Injection for the Treatment of Pain After Endoscopic Surgery of the Lower Abdominal

A Phase Ⅲ, Randomized, Double-blind, Placebo- and Active-controlled Study of SHR0410 Injection for the Treatment of Pain After Endoscopic Surgery of the Lower Abdominal

The study is being conducted to evaluate the efficacy and safety of SHR0410 injection for the treatment of pain after endoscopic surgery of the lower abdominal.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Morphine; Drug: SHR0410 Injection; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 228
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital of Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (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. Subjects with an oxygen saturation below 90% on room air
11. Allergic to drugs that may be used during the study
12. Pregnant or nursing women
13. No birth control during the specified period of time
14. Participated in clinical trials of other drugs (received experimental drugs)
15. 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
Active Comparator: Morphine	Drug: Morphine; Morphine
Placebo Comparator: Placebo for SHR0410 Injection	Drug: Placebo; Placebo for SHR0410 Injection
Experimental: SHR0410 Injection	Drug: SHR0410 Injection; SHR0410 Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The area under the curve of pain intensity over 24 hours	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 24 hours.	24-hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24-hours
Total consumption of remedial analgesics from 0h to 24h	Total consumption of IV morphine	24-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.	24-hours
Frequency and severity of adverse events	Assessed by monitoring of adverse events. Participants with adverse events found to be related to the study drug will be compared to those receiving placebo or active comparator.	Day 4（or early termination on Day 3）
Safety as assessed by vital signs	Changes in vital signs such as body temperature, blood pressure, heart rate will be assessed at specified times.	Day 4（or early termination on Day 3）
Safety as assessed by laboratory evaluations	Assessed by laboratory evaluations at specified times. Participants with clinically significant lab values will be compared to those receiving placebo or active comparator.	Day 4（or early termination on Day 3）

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2021
• Primary Completion (Actual): June 26, 2021
• Study Completion (Actual): July 22, 2021

Study Registration Dates

• First Submitted: April 15, 2021
• First Submitted That Met QC Criteria: April 19, 2021
• First Posted (Actual): April 21, 2021

Study Record Updates

• Last Update Posted (Actual): February 10, 2022
• Last Update Submitted That Met QC Criteria: January 27, 2022
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: SHR0410-301

Drug and device information, study documents

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