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.

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

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: SHR8554 Injection; Drug: SHR8554 Injection; Drug: Morphine; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 528
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Wuhan
    • Wuhan, Wuhan, China, 430021
      • Union Hospital Affiliated to Tongji Medical Collage Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Able and willing to provide a written informed consent
2. Subjects requiring elective general anesthesia abdominal surgery
3. Conform to the ASA Physical Status Classification

Exclusion Criteria:

1. Subjects with a history of difficult airway
2. Subjects with a history of reflux esophagitis
3. Subjects with a history of mental illness
4. Subjects with poor blood pressure control
5. Transcutaneous oxygen saturation (SpO2) <90%
6. Random blood glucose ≥11.1mmol/L
7. Subjects with abnormal liver function
8. allergies to opioids and other medications that may be used during the trial
9. Pregnant or nursing women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group A	Drug: SHR8554 Injection; SHR8554 Injection; high dose; Drug: SHR8554 Injection; SHR8554 Injection; low dose
Experimental: Treatment group B	Drug: SHR8554 Injection; SHR8554 Injection; high dose; Drug: SHR8554 Injection; SHR8554 Injection; low dose
Placebo Comparator: Treatment group C	Drug: Placebo; Saline Solution
Active Comparator: Treatment group D	Drug: Morphine; Morphine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant ' satisfaction score for analgesia treatment	Participants recalled the postoperative analgesia effect and rated their satisfaction on a scale of 0 to 10, with 0 representing dissatisfied and 10 representing very satisfied.	24-hours
Investigator satisfaction score for analgesia treatment	Postoperative analgesia was evaluated by investigators.The scale ranges from 0 to 10, with 0 being dissatisfied and 10 being very satisfied.	24-hours
the Sum of Pain Intensity Differences in Pain Score Over 6、12、18 、12-18 Hours	time weighted sum of pain intensity differences (SPID) divided by a constant (6、12、18 、12-18 hours) to yield values on the 0-10 NPRS.	6-hours、12-hours、18-hours、12-18 hours
Time of first use of remedial analgesic medication	The first time to use parecoxib sodium for injection	24-hours
Cumulative use of remedial analgesics from 0h to 24h	Cumulative use of parecoxib sodium for injection / sufentanil hydrochloride injection	24-hours

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2021
• Primary Completion (Actual): October 19, 2021
• Study Completion (Actual): November 1, 2021

Study Registration Dates

• First Submitted: February 9, 2021
• First Submitted That Met QC Criteria: February 22, 2021
• First Posted (Actual): February 23, 2021

Study Record Updates

• Last Update Posted (Actual): July 6, 2022
• Last Update Submitted That Met QC Criteria: July 4, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: SHR8554-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No