A Clinical Study of SHR8554 Injection for the Treatment of Pain After Abdominal Surgery.
A Phase III, Randomized, Double-Blind, Placebo- and Active-controlled Study of SHR8554 Injection for the Treatment of Pain After Abdominal Surgery.
1 other identifier
interventional
528
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 abdominal surgery
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 pain
Started Mar 2021
Shorter than P25 for phase_3 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
February 9, 2021
CompletedFirst Posted
Study publicly available on registry
February 23, 2021
CompletedStudy Start
First participant enrolled
March 3, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 19, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2021
CompletedJuly 6, 2022
July 1, 2022
8 months
February 9, 2021
July 4, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
the Sum of Pain Intensity Differences in Pain Score Over 24 Hours
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 24 hours. Time weighted average change from baseline is calculated using the following: time weighted sum of pain intensity differences (SPID) divided by a constant (24 hours) to yield values on the 0-10 NPRS.
24-hours
Secondary Outcomes (5)
the Sum of Pain Intensity Differences in Pain Score Over 6、12、18 、12-18 Hours
6-hours、12-hours、18-hours、12-18 hours
Time of first use of remedial analgesic medication
24-hours
Cumulative use of remedial analgesics from 0h to 24h
24-hours
Participant ' satisfaction score for analgesia treatment
24-hours
Investigator satisfaction score for analgesia treatment
24-hours
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 abdominal 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)
Union Hospital Affiliated to Tongji Medical Collage Huazhong University of Science and Technology
Wuhan, Wuhan, 430021, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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
Study Record Dates
First Submitted
February 9, 2021
First Posted
February 23, 2021
Study Start
March 3, 2021
Primary Completion
October 19, 2021
Study Completion
November 1, 2021
Last Updated
July 6, 2022
Record last verified: 2022-07