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

Phase 3

Completed

• Conditions: Pain
• Interventions: Drug: SHR0410 Injection; Drug: Placebo; Drug: Morphine

• Registration Number: NCT04852003
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-04
• Study First Submitted: 2021-04-15
• Study First Submitted QC: 2021-04-19
• Study First Posted: 2021-04-21
• Study Start: 2021-05-13
• Primary Completion: 2021-06-26
• Study Completion: 2021-07-22
• Last Update Submitted: 2022-01-27
• Last Update Posted: 2022-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 228

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SHR0410 Injection	SHR0410 Injection	-
Placebo for SHR0410 Injection	Placebo	-
Morphine	Morphine	-

Primary Outcome Measures

Name	Time	Method
The area under the curve of pain intensity over 24 hours	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.

Secondary Outcome Measures

Name	Time	Method
Total consumption of remedial analgesics from 0h to 24h	24-hours	Total consumption of IV morphine
Participant ' satisfaction score for analgesia treatment	24-hours	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.
Investigator satisfaction score for analgesia treatment	24-hours	Postoperative analgesia was evaluated by investigators. The scale ranges from 0 to 10, with 0 being dissatisfied and 10 being very satisfied.
Frequency and severity of adverse events	Day 4（or early termination on Day 3）	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.
Safety as assessed by vital signs	Day 4（or early termination on Day 3）	Changes in vital signs such as body temperature, blood pressure, heart rate will be assessed at specified times.
Safety as assessed by laboratory evaluations	Day 4（or early termination on Day 3）	Assessed by laboratory evaluations at specified times. Participants with clinically significant lab values will be compared to those receiving placebo or active comparator.

Trial Locations

Locations (1)

West China Hospital of Sichuan University; 🇨🇳 Chengdu, Sichuan, China