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

Hengrui Medicine

Status and phase: Completed; Phase 3

Conditions: Pain

Treatments: Drug: Morphine; Drug: Placebo; Drug: SHR8554 Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT04766463

SHR8554-301

Details and patient eligibility

About

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

Enrollment: 528 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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528 participants in 4 patient groups, including a placebo group

Treatment group A

Experimental group

Treatment:

Drug: SHR8554 Injection

Drug: SHR8554 Injection

Treatment group B

Experimental group

Treatment:

Drug: SHR8554 Injection

Drug: SHR8554 Injection

Treatment group C

Placebo Comparator group

Treatment:

Drug: Placebo

Treatment group D

Active Comparator group

Treatment:

Drug: Morphine