A Clinical Study of SHR8554 Injection for the Treatment of Pain After Orthopedic Surgery

Pain Clinical Trial

Official title:

A Phase II/III, Randomized, Double-Blind, Placebo- and Active-controlled Study of SHR8554 Injection for the Treatment of Pain After Orthopedic Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04794738
• Other study ID #: SHR8554-202
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: April 18, 2021
• Est. completion date: October 30, 2021

Study information

• Verified date: March 2021
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Yong Cao, M.M
• Phone: +0518-81220121
• Email: caoyong[@]hrs.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 192
• Est. completion date: October 30, 2021
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Able and willing to provide a written informed consent

2. Subjects requiring elective general anesthesia orthopedic 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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• SHR8554
SHR8554 Injection; high dose
• SHR8554
SHR8554 Injection; low dose
• Saline Solution
Saline Solution
• Morphine
Morphine

Locations

Country	Name	City	State
China	Shanghai Jiaotong University School of Medicine,Renji Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	the Sum of Pain Intensity Differences in Pain Score Over 6?12?48 ?12-24?24-48 Hours under static condition		48-hours
Secondary	the Sum of Pain Intensity Differences in Pain Score Over 6?12?24?48 ?12-24?24-48 Hours under moving condition		48-hours
Secondary	Time of first use of remedial analgesic medication		48-hours
Secondary	Cumulative use of remedial analgesics from 0h to 48h		48-hours
Secondary	Participant ' satisfaction score for analgesia treatment		48-hours
Secondary	Investigator satisfaction score for analgesia treatment		48-hours