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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04766463
• Other study ID #: SHR8554-301
• Status: Completed
• Phase: Phase 3
• Start date: March 3, 2021
• Est. completion date: November 1, 2021

Study information

• Verified date: July 2022
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• 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 abdominal surgery

Recruitment information / eligibility

• Status: Completed
• Enrollment: 528
• Est. completion date: November 1, 2021
• Est. primary completion date: October 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

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

Locations

Country	Name	City	State
China	Union Hospital Affiliated to Tongji Medical Collage Huazhong University of Science and Technology	Wuhan	Wuhan

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 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	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
Secondary	Time of first use of remedial analgesic medication	The first time to use parecoxib sodium for injection	24-hours
Secondary	Cumulative use of remedial analgesics from 0h to 24h	Cumulative use of parecoxib sodium for injection / sufentanil hydrochloride injection	24-hours
Secondary	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
Secondary	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