A Trial of SHR0410 Injection in Postsurgical Pain Management

Hengrui Medicine

Status and phase: Enrolling; Phase 2

Conditions: Postsurgical Pain

Treatments: Drug: Placebo for SHR0410 Injection; Drug: SHR0410 Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT05394402

SHR0410-202

Details and patient eligibility

About

The study is being conducted to evaluate the efficacy, safety of SHR0410 Injection and to explore the reasonable of SHR0410 Injection for Pain Management after Orthopaedic Surgery.

Enrollment: 108 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Able and willing to provide a written informed consent；
2. Subjects requiring elective general anesthesia orthopedic surgery；
3. Male or female；
4. Meet the body mass index standard；
5. Conform to the ASA Physical Status Classification；
6. Negative pregnancy test.

Exclusion criteria

1. Subjects with a history of myocardial infarction or unstable angina pectoris；
2. Subjects with atrioventricular block or cardiac insufficiency；
3. Subjects with a history of malignancy ；
4. Subjects with a history of stroke；
5. Subjects with a history of mental illness；
6. Subjects with a history of difficult airway；
7. Random blood glucose ≥11.1mmol/L；
8. Subjects with poor blood pressure control；
9. Abnormal values in liver or renal function；
10. Subject with a history of substance abuse and drug abuse；
11. Allergic to drugs that may be used during the study；
12. Use other drugs that affect the analgesic effect before randomization, and the time from the last use to randomization is shorter than 5 half-lives；
13. Participated in clinical trials of other drugs (received experimental drugs)；
14. Other circumstances that the investigator judged inappropriate for participation in this clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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108 participants in 3 patient groups, including a placebo group

SHR0410 Injection High dose

Experimental group

Treatment:

Drug: SHR0410 Injection

SHR0410 Injection Low dose

Experimental group

Treatment:

Drug: SHR0410 Injection

Placebo for SHR0410 Injection

Placebo Comparator group

Treatment:

Drug: Placebo for SHR0410 Injection