NCT05459220UnknownPhase 3
A Phase Ⅲ, Randomized, Double-blind, Placebo-controlled Study of SHR0410 Injection for the Treatment of Pain After Laparoscopic Surgery
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Enrollment
- 357
- Primary Endpoint
- Summed Pain Intensity Difference From 0-24 Hours (SPID0-24)
Study Overview
Brief Summary
The study is being conducted to evaluate the efficacy and safety of SHR0410 injection for the treatment of pain after laparoscopic surgery
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Treatment group A
Experimental
SHR0410 Injection（Low Dose）
Intervention: SHR0410 Injection (Drug)
Treatment group B
Experimental
SHR0410 Injection（High Dose）
Intervention: SHR0410 Injection (Drug)
Treatment group C
Placebo Comparator
Placebo for SHR0410 Injection.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Summed Pain Intensity Difference From 0-24 Hours (SPID0-24)
Time Frame: 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 Outcomes
- 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)
- Investigator Satisfaction Score For Analgesia Treatment(24-hours)
- Numbers of Participants With Abnormal Vital Signs(Day 3 or Day 4)
- Numbers of Participants With Abnormal Laboratory Values(Day 3 or Day 4)
- 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)
Investigators
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