A Trial of SHR0410 Injection for the Treatment of Pain After Laparoscopic Surgery

Hengrui Medicine

Status and phase: Not yet enrolling; Phase 3

Conditions: Postoperative Pain Of Laparoscopic Surgery

Treatments: Drug: SHR0410 Injection; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05459220

SHR0410-302

Details and patient eligibility

About

The study is being conducted to evaluate the efficacy and safety of SHR0410 injection for the treatment of pain after laparoscopic surgery

Enrollment: 357 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 endoscopic surgery of the lower abdominal
3. Male or female
4. Meet the body mass index standard
5. Conform to the ASA Physical Status Classification

Exclusion criteria

1. Subjects with a history of difficult airway
2. Subjects with a history of mental illness
3. Subjects with a history of cognitive impairment epilepsy
4. Subjects with a history of myocardial infarction or unstable angina pectoris
5. Subjects with atrioventricular block or cardiac insufficiency
6. Subjects with a history of ischemic stroke or transient ischemic attack
7. Subjects with poor blood pressure control after medication
8. Subject with a history of substance abuse and drug abuse
9. Abnormal values in liver function
10. Allergic to drugs that may be used during the study
11. Pregnant or nursing women
12. No birth control during the specified period of time
13. Participated in clinical trials of other drugs (received experimental drugs)
14. 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

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357 participants in 3 patient groups, including a placebo group

Treatment group A

Experimental group

Description:

SHR0410 Injection（Low Dose）

Treatment:

Drug: SHR0410 Injection

Drug: SHR0410 Injection

Treatment group B

Experimental group

Description:

SHR0410 Injection（High Dose）

Treatment:

Drug: SHR0410 Injection

Drug: SHR0410 Injection

Treatment group C

Placebo Comparator group

Description:

Placebo for SHR0410 Injection.

Treatment:

Drug: Placebo