A Study of SHR8554 Injection for the Treatment of Pain After Orthopedic Surgery
A Phase II/Ⅲ, Randomized, Double-Blind, Dose-explored, Active-controlled Study of SHR8554 Injection for the Treatment of Pain After Orthopedic Surgery
1 other identifier
interventional
320
1 country
1
Brief Summary
The primary objective is to evaluate the analgesic efficacy of IV SHR8554 compared with morphine and placebo in patients with acute postoperative pain following orthopedic surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 pain
Started May 2022
Typical duration for phase_2 pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2022
CompletedStudy Start
First participant enrolled
May 11, 2022
CompletedFirst Posted
Study publicly available on registry
May 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 19, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 19, 2023
CompletedDecember 26, 2023
October 1, 2023
1.4 years
May 11, 2022
December 22, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
the Sum of Pain Intensity Differences in Pain Score Over 48 Hours in the rest state
Pain intensity will be evaluated using an 11-point (0-10) Numeric Pain Rating Scale (NPRS), with higher numbers indicating a higher pain intensity, administered over 48 hours. Time weighted average change from baseline is calculated using the following: time weighted sum of pain intensity differences (SPID) divided by a constant (48 hours) to yield values on the 0-10 NPRS.
48-hours
Secondary Outcomes (5)
the Sum of Pain Intensity Differences in Pain Score Over 6、12、24、 48 、12-24、24-48 Hours under static and moving condition
48-hours
Time of first use of remedial analgesic medication
48-hours
Cumulative use of remedial analgesics from 0h to 48h
48-hours
Participant ' satisfaction score for analgesia treatment
48-hours
Investigator satisfaction score for analgesia treatment
48-hours
Study Arms (4)
Treatment group A：SHR8554 Injection
EXPERIMENTALTreatment group B：SHR8554 Injection
EXPERIMENTALTreatment group C：Saline Solution
PLACEBO COMPARATORTreatment group D：Morphine
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Able and willing to provide a written informed consent
- Subjects requiring elective general anesthesia orthopedic surgery
- Conform to the ASA Physical Status Classification
You may not qualify if:
- Subjects with a history of difficult airway
- Subjects with a history of reflux esophagitis
- Subjects with a history of mental illness
- Subjects with poor blood pressure control
- Transcutaneous oxygen saturation (SpO2) \<90%
- Random blood glucose ≥11.1mmol/L
- Subjects with abnormal liver function
- allergies to opioids and other medications that may be used during the trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Jiaotong University School of Medicine,Renji Hospital
Shanghai, Shanghai Municipality, 200127, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2022
First Posted
May 16, 2022
Study Start
May 11, 2022
Primary Completion
October 19, 2023
Study Completion
October 19, 2023
Last Updated
December 26, 2023
Record last verified: 2023-10