A Clinical Study of SHR8554 Injection for the Treatment of Pain After Abdominal Surgery.
NCT ID: NCT04766463
Last Updated: 2022-07-06
Study Results
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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COMPLETED
PHASE3
528 participants
INTERVENTIONAL
2021-03-03
2021-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Treatment group A
SHR8554 Injection
SHR8554 Injection; high dose
Treatment group B
SHR8554 Injection
SHR8554 Injection; low dose
Treatment group C
Placebo
Saline Solution
Treatment group D
Morphine
Morphine
Interventions
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SHR8554 Injection
SHR8554 Injection; high dose
SHR8554 Injection
SHR8554 Injection; low dose
Placebo
Saline Solution
Morphine
Morphine
Eligibility Criteria
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Inclusion Criteria
2. Subjects requiring elective general anesthesia abdominal surgery
3. Conform to the ASA Physical Status Classification
Exclusion Criteria
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
18 Years
65 Years
ALL
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Union Hospital Affiliated to Tongji Medical Collage Huazhong University of Science and Technology
Wuhan, Wuhan, China
Countries
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Other Identifiers
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SHR8554-301
Identifier Type: -
Identifier Source: org_study_id
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