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

• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05459220
• Collaborator: (none)
• Enrollment: 357
• Arms: 3
• Anticipated Duration (Months): 8

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 laparoscopic surgery

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain Of Laparoscopic Surgery	Drug: SHR0410 Injection; Drug: SHR0410 Injection; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 357 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: SHR0410 injection compared with placeboSHR0410 injection compared with placebo
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase Ⅲ, Randomized, Double-blind, Placebo-controlled Study of SHR0410 Injection for the Treatment of Pain After Laparoscopic Surgery
• Anticipated Study Start Date: Jul 1, 2022
• Anticipated Primary Completion Date: Feb 28, 2023
• Anticipated Study Completion Date: Feb 28, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment group A SHR0410 Injection（Low Dose）	Drug: SHR0410 Injection; SHR0410 Injection（Low Dose）
Experimental: Treatment group B SHR0410 Injection（High Dose）	Drug: SHR0410 Injection; SHR0410 Injection（High Dose）
Placebo Comparator: Treatment group C Placebo for SHR0410 Injection.	Drug: Placebo; Placebo for SHR0410 Injection.

Outcome Measures

Primary Outcome Measures

1. Summed Pain Intensity Difference From 0-24 Hours (SPID0-24) [0 to 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.

Secondary Outcome Measures

1. Summed Pain Intensity Difference Within The First 2 Hours、4 Hours、6 Hours、12 Hours、18 Hours (SPID2、SPID4、SPID6、 SPID12、SPID18) [0 to 2 hours、0 to 4 hours、0 to 6 hours、0 to 12 hours、0 to 18 hours]

   Pain intensity will be evaluated using an 11-point (0-10) numeric rating scale (NRS), with higher numbers indicating a higher pain intensity.

2. Estimated Time From The Start Of The Infusion Of Study Drug To The First NRS reaching 3 or less [0 to 24 hours]

3. Total Pain Relief Within The First 2 Hours、4 Hours、6 Hours、12 Hours、18 Hours、24 Hours [0 to 2 hours、0 to 4 hours、0 to 6 hours、0 to 12 hours、0 to 18 hours、0 to 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".

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

5. Participant' Satisfaction Score For Analgesia Treatment [24-hours]

6. Investigator Satisfaction Score For Analgesia Treatment [24-hours]

7. Numbers of Participants With Abnormal Vital Signs [Day 3 or Day 4]

   Changes in vital signs such as body temperature (using the celsius system) will be assessed at specified times.

8. Numbers of Participants With Abnormal Vital Signs [Day 3 or Day 4]

   Changes in vital signs such as, blood pressure (using mmHg) will be assessed at specified times.

9. Numbers of Participants With Abnormal Vital Signs [Day 3 or Day 4]

   Changes in vital signs such as , heart rate (measured by beats per minute) will be assessed at specified times.

10. Numbers of Participants With Abnormal Laboratory Values [Day 3 or Day 4]

    Participants with clinically significant lab values will be compared to those receiving placebo comparator.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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. 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

Contacts and Locations

Locations

No locations specified.

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: NCT05459220
• Other Study ID Numbers: SHR0410-302
• First Posted: Jul 14, 2022
• Last Update Posted: Jul 14, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pain, Postoperative

Study Results

No Results Posted as of Jul 14, 2022