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

NCT ID: NCT05470049

Last Updated: 2022-07-22

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

PHASE2

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2022-11-30

Brief Summary

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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

Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment group A: SHR8554 Injection and SHR0410 Injection

Group Type EXPERIMENTAL

SHR8554 Injection and SHR0410 Injection

Intervention Type DRUG

Treatment group A: SHR8554 Injection and SHR0410 Injection; high dose

Treatment group B: SHR8554 Injection and SHR0410 Injection

Group Type EXPERIMENTAL

SHR8554 Injection and SHR0410 Injection

Intervention Type DRUG

Treatment group B: SHR8554 Injection and SHR0410 Injection; low dose

Treatment group C: SHR8554 Injection and Placebo for SHR0410 Injection

Group Type PLACEBO_COMPARATOR

SHR8554 Injection and Placebo for SHR0410 Injection

Intervention Type DRUG

Treatment group C: SHR8554 Injection and Placebo for SHR0410 Injection

Interventions

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SHR8554 Injection and SHR0410 Injection

Treatment group A: SHR8554 Injection and SHR0410 Injection; high dose

Intervention Type DRUG

SHR8554 Injection and SHR0410 Injection

Treatment group B: SHR8554 Injection and SHR0410 Injection; low dose

Intervention Type DRUG

SHR8554 Injection and Placebo for SHR0410 Injection

Treatment group C: SHR8554 Injection and 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 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. Random blood glucose ≥11.1mmol/L
6. Subjects with abnormal liver function
7. allergies to opioids and other medications that may be used during the trial
8. 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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SHR8554/SHR0410-201

Identifier Type: -

Identifier Source: org_study_id

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