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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04852003
• Other study ID #: SHR0410-301
• Status: Completed
• Phase: Phase 3
• Start date: May 13, 2021
• Est. completion date: July 22, 2021

Study information

• Verified date: April 2021
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 228
• Est. completion date: July 22, 2021
• Est. primary completion date: June 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• SHR0410 Injection
SHR0410 Injection
• Placebo
Placebo for SHR0410 Injection
• Morphine
Morphine

Locations

Country	Name	City	State
China	West China Hospital of Sichuan University	Chengdu	Sichuan

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	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	Total consumption of remedial analgesics from 0h to 24h	Total consumption of IV morphine	24-hours
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.	24-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.	24-hours
Secondary	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)
Secondary	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)
Secondary	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)