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CompletedNCT04766463Updated Jul 6, 2022

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

A Phase 3 interventional study of SHR8554 Injection and SHR8554 Injection in Pain, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-07-06.

Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
528
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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

02

Conditions studied

  • Pain
03

In context

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 559 studies on the registry; 85 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
528 participants (actual)

Study arms

  • Experimental
    Treatment group A

    Drug: SHR8554 Injection

  • Experimental
    Treatment group B

    Drug: SHR8554 Injection

  • Placebo comparator
    Treatment group C

    Drug: Placebo

  • Active comparator
    Treatment group D

    Drug: Morphine

Interventions

  • DrugSHR8554 Injection

    SHR8554 Injection; high dose

  • DrugSHR8554 Injection

    SHR8554 Injection; low dose

  • DrugPlacebo

    Saline Solution

  • DrugMorphine

    Morphine

06

What researchers measure

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.

    Time frame: 24-hours

Secondary outcomes

  1. 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.

    Time frame: 6-hours、12-hours、18-hours、12-18 hours

  2. Time of first use of remedial analgesic medication

    The first time to use parecoxib sodium for injection

    Time frame: 24-hours

  3. Cumulative use of remedial analgesics from 0h to 24h

    Cumulative use of parecoxib sodium for injection / sufentanil hydrochloride injection

    Time frame: 24-hours

  4. 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.

    Time frame: 24-hours

  5. 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.

    Time frame: 24-hours

07

Study locations

1 site
  • Union Hospital Affiliated to Tongji Medical Collage Huazhong University of Science and Technology
    Wuhan, Wuhan 430021, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 6, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04766463
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Responsible party
Sponsor
First posted
Feb 23, 2021
Start date
Mar 3, 2021
Primary completion
Oct 19, 2021
Completion
Nov 1, 2021
Last update
Jul 6, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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