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

NCT05459220 | Unknown Phase 3

• 1 other identifier: SHR0410-302
• Study Type: interventional
• Target: 357
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study is being conducted to evaluate the efficacy and safety of SHR0410 injection for the treatment of pain after laparoscopic surgery

Conditions

Postoperative Pain Of Laparoscopic Surgery

Outcome Measures

Primary Outcomes (1)

• Summed Pain Intensity Difference From 0-24 Hours (SPID0-24)

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

  0 to 24 hours

Secondary Outcomes (10)

• 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

• Estimated Time From The Start Of The Infusion Of Study Drug To The First NRS reaching 3 or less

  0 to 24 hours

• 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

• Total consumption of remedial analgesics from 0 to 24 hours

  24-hours

• Participant' Satisfaction Score For Analgesia Treatment

  24-hours

Study Arms (3)

Treatment group A

EXPERIMENTAL

SHR0410 Injection（Low Dose）

Drug: SHR0410 Injection

Treatment group B

EXPERIMENTAL

SHR0410 Injection（High Dose）

Drug: SHR0410 Injection

Treatment group C

PLACEBO COMPARATOR

Placebo for SHR0410 Injection.

Drug: Placebo

Interventions

SHR0410 Injection DRUG

SHR0410 Injection（Low Dose）

Treatment group A

Placebo DRUG

Placebo for SHR0410 Injection.

Treatment group C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to provide a written informed consent
• Subjects requiring elective general anesthesia endoscopic surgery of the lower abdominal
• Male or female
• Meet the body mass index standard
• Conform to the ASA Physical Status Classification

You may not qualify if:

• Subjects with a history of difficult airway
• Subjects with a history of mental illness
• Subjects with a history of cognitive impairment epilepsy
• Subjects with a history of myocardial infarction or unstable angina pectoris
• Subjects with atrioventricular block or cardiac insufficiency
• Subjects with a history of ischemic stroke or transient ischemic attack
• Subjects with poor blood pressure control after medication
• Subject with a history of substance abuse and drug abuse
• Abnormal values in liver function
• Allergic to drugs that may be used during the study
• Pregnant or nursing women
• No birth control during the specified period of time
• Participated in clinical trials of other drugs (received experimental drugs)
• The investigators determined that other conditions were inappropriate for participation in this clinical trial

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Central Study Contacts

Qin Liu

CONTACT

+0518-82342973; qin.liu@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: SHR0410 injection compared with placebo

Study Record Dates

• First Submitted: June 30, 2022
• First Posted: July 14, 2022
• Study Start: July 1, 2022
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: July 14, 2022

Record last verified: 2022-06