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

• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04852003
• Collaborator: (none)
• Enrollment: 228
• Location: 1
• Arms: 3
• Actual Duration (Months): 2.3
• Patients Per Site Per Month: 99.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain	Drug: SHR0410 Injection; Drug: Placebo; Drug: Morphine	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 228 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: SHR0410 injection compared with placebo and morphineSHR0410 injection compared with placebo and morphine
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: May 13, 2021
• Actual Primary Completion Date: Jun 26, 2021
• Actual Study Completion Date: Jul 22, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SHR0410 Injection	Drug: SHR0410 Injection; SHR0410 Injection
Placebo Comparator: Placebo for SHR0410 Injection	Drug: Placebo; Placebo for SHR0410 Injection
Active Comparator: Morphine	Drug: Morphine; Morphine

Outcome Measures

Primary Outcome Measures

1. 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

1. Total consumption of remedial analgesics from 0h to 24h [24-hours]

   Total consumption of IV morphine

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	West China Hospital of Sichuan University	Chengdu	Sichuan	China	610041

Sponsors and Collaborators

• Jiangsu HengRui Medicine Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04852003
• Other Study ID Numbers: SHR0410-301
• First Posted: Apr 21, 2021
• Last Update Posted: Feb 10, 2022
• Last Verified: Apr 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Morphine

Study Results

No Results Posted as of Feb 10, 2022