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

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Hengrui Medicine

Status and phase

Not yet enrolling
Phase 2

Conditions

Pain

Treatments

Drug: SHR8554 Injection and SHR0410 Injection
Drug: SHR8554 Injection and Placebo for SHR0410 Injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT05470049
SHR8554/SHR0410-201

Details and patient eligibility

About

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

Enrollment

108 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Subjects with a history of difficult airway
  • Subjects with a history of reflux esophagitis
  • Subjects with a history of mental illness
  • Subjects with poor blood pressure control
  • Random blood glucose ≥11.1mmol/L
  • Subjects with abnormal liver function
  • allergies to opioids and other medications that may be used during the trial
  • The investigators determined that other conditions were inappropriate for participation in this clinical trial

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

108 participants in 3 patient groups, including a placebo group

Treatment group A: SHR8554 Injection and SHR0410 Injection
Experimental group
Treatment:
Drug: SHR8554 Injection and SHR0410 Injection
Treatment group B: SHR8554 Injection and SHR0410 Injection
Experimental group
Treatment:
Drug: SHR8554 Injection and SHR0410 Injection
Treatment group C: SHR8554 Injection and Placebo for SHR0410 Injection
Placebo Comparator group
Treatment:
Drug: SHR8554 Injection and Placebo for SHR0410 Injection

Trial contacts and locations

0

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Central trial contact

Qin Liu

Data sourced from clinicaltrials.gov

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