Clinical trial NCT05459220: A Trial of SHR0410 Injection for the Treatment of Pain After Laparoscopic Surgery
Official title: A Phase Ⅲ, Randomized, Double-blind, Placebo-controlled Study of SHR0410 Injection for the Treatment of Pain After Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Postoperative Pain Of Laparoscopic Surgery
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-07-14
Enrollment: 357
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: SHR0410 injection compared with placebo
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Summed Pain Intensity Difference From 0-24 Hours (SPID0-24)
timeFrame: 0 to 24 hours
Secondary outcomes:
measure: Summed Pain Intensity Difference Within The First 2 Hours、4 Hours、6 Hours、12 Hours、18 Hours (SPID2、SPID4、SPID6、 SPID12、SPID18)
timeFrame: 0 to 2 hours、0 to 4 hours、0 to 6 hours、0 to 12 hours、0 to 18 hours
measure: Estimated Time From The Start Of The Infusion Of Study Drug To The First NRS reaching 3 or less
timeFrame: 0 to 24 hours
measure: Total Pain Relief Within The First 2 Hours、4 Hours、6 Hours、12 Hours、18 Hours、24 Hours
timeFrame: 0 to 2 hours、0 to 4 hours、0 to 6 hours、0 to 12 hours、0 to 18 hours、0 to 24 hours
measure: Total consumption of remedial analgesics from 0 to 24 hours
timeFrame: 24-hours
measure: Participant' Satisfaction Score For Analgesia Treatment
timeFrame: 24-hours
measure: Investigator Satisfaction Score For Analgesia Treatment
timeFrame: 24-hours
measure: Numbers of Participants With Abnormal Vital Signs
timeFrame: Day 3 or Day 4
measure: Numbers of Participants With Abnormal Vital Signs
timeFrame: Day 3 or Day 4
measure: Numbers of Participants With Abnormal Vital Signs
timeFrame: Day 3 or Day 4
measure: Numbers of Participants With Abnormal Laboratory Values
timeFrame: Day 3 or Day 4
Other outcomes:
Locations:
Study officials:
References: