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

NCT ID: NCT04766463

Last Updated: 2022-07-06

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

528 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-03

Study Completion Date

2021-11-01

Brief Summary

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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

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

Group Type EXPERIMENTAL

SHR8554 Injection

Intervention Type DRUG

SHR8554 Injection; high dose

Treatment group B

Group Type EXPERIMENTAL

SHR8554 Injection

Intervention Type DRUG

SHR8554 Injection; low dose

Treatment group C

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Saline Solution

Treatment group D

Group Type ACTIVE_COMPARATOR

Morphine

Intervention Type DRUG

Morphine

Interventions

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SHR8554 Injection

SHR8554 Injection; high dose

Intervention Type DRUG

SHR8554 Injection

SHR8554 Injection; low dose

Intervention Type DRUG

Placebo

Saline Solution

Intervention Type DRUG

Morphine

Morphine

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. 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 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

Locations

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Union Hospital Affiliated to Tongji Medical Collage Huazhong University of Science and Technology

Wuhan, Wuhan, China

Site Status

Countries

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China

Other Identifiers

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SHR8554-301

Identifier Type: -

Identifier Source: org_study_id

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