A Clinical Study of the Combination of SHR8554 Injection and SHR0410 Injection for the Treatment of Pain After Abdominal Surgery.

A Phase II, Randomized, Double-Blind Study of the Combination of SHR8554 Injection and SHR0410 Injection for the Treatment of Pain After Abdominal Surgery.

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05470049

Enrollment

108

Registered

2022-07-22

Start date

2022-08-01

Completion date

2022-11-30

Last updated

2022-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Brief summary

The primary objective is to evaluate the analgesic efficacy of the combination of SHR8554 injection and SHR0410 injection compared with SHR8554 injection in patients with acute postoperative pain following abdominal surgery

Interventions

DRUGSHR8554 Injection and SHR0410 Injection

Treatment group A: SHR8554 Injection and SHR0410 Injection; high dose

DRUGSHR8554 Injection and Placebo for SHR0410 Injection

Treatment group C: SHR8554 Injection and Placebo for SHR0410 Injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

Parallel Assignment

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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. Random blood glucose ≥11.1mmol/L 6. Subjects with abnormal liver function 7. allergies to opioids and other medications that may be used during the trial 8. The investigators determined that other conditions were inappropriate for participation in this clinical trial

Design outcomes

Primary

Measure	Time frame	Description
the Sum of Pain Intensity Differences in Pain Score Over 24 Hours	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.

Secondary

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

Contacts

Primary ContactQin Liu

qin.liu@hengrui.com+0518-82342973

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026