A Clinical Study of SHR8554 Injection for the Treatment of Pain After Orthopedic Surgery
A Phase II/III, Randomized, Double-Blind, Placebo- and Active-controlled Study of SHR8554 Injection for the Treatment of Pain After Orthopedic Surgery
1 other identifier
interventional
192
1 country
1
Brief Summary
The primary objective is to evaluate the analgesic efficacy of IV SHR8554 compared with placebo and morphine 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 Apr 2021
Shorter than P25 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
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 9, 2021
CompletedFirst Posted
Study publicly available on registry
March 12, 2021
CompletedStudy Start
First participant enrolled
April 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2021
CompletedAugust 12, 2021
March 1, 2021
7 months
March 9, 2021
August 5, 2021
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 (6)
the Sum of Pain Intensity Differences in Pain Score Over 6、12、48 、12-24、24-48 Hours under static condition
48-hours
the Sum of Pain Intensity Differences in Pain Score Over 6、12、24、48 、12-24、24-48 Hours under 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
- +1 more secondary outcomes
Study Arms (4)
Treatment group A
EXPERIMENTALTreatment group B
EXPERIMENTALTreatment group C
PLACEBO COMPARATORTreatment group D
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
- Pregnant or nursing women
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)
Central Study Contacts
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
March 9, 2021
First Posted
March 12, 2021
Study Start
April 18, 2021
Primary Completion
October 30, 2021
Study Completion
October 30, 2021
Last Updated
August 12, 2021
Record last verified: 2021-03