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

NCT ID: NCT05459220

Last Updated: 2022-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

357 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-31

Study Completion Date

2023-02-28

Brief Summary

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

Detailed Description

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Conditions

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Postoperative Pain Of Laparoscopic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

SHR0410 injection compared with placebo
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment group A

SHR0410 Injection(Low Dose)

Group Type EXPERIMENTAL

SHR0410 Injection

Intervention Type DRUG

SHR0410 Injection(Low Dose)

Treatment group B

SHR0410 Injection(High Dose)

Group Type EXPERIMENTAL

SHR0410 Injection

Intervention Type DRUG

SHR0410 Injection(High Dose)

Treatment group C

Placebo for SHR0410 Injection.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo for SHR0410 Injection.

Interventions

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SHR0410 Injection

SHR0410 Injection(Low Dose)

Intervention Type DRUG

SHR0410 Injection

SHR0410 Injection(High Dose)

Intervention Type DRUG

Placebo

Placebo for SHR0410 Injection.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Qin Liu

Role: CONTACT

+0518-82342973

Other Identifiers

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SHR0410-302

Identifier Type: -

Identifier Source: org_study_id

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