Clinical Study of HRS-2129 for Postoperative Analgesia in Orthopaedics
NCT ID: NCT06780267
Last Updated: 2025-11-18
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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RECRUITING
PHASE1/PHASE2
195 participants
INTERVENTIONAL
2025-03-11
2026-02-28
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: low\middle\high-dose
HRS-2129； HRS-2129 placebo
HRS-2129
HRS-2129
HRS-2129 placebo
HRS-2129 placebo
Treatment group:placebo
HRS-2129 placebo
HRS-2129 placebo
HRS-2129 placebo
Treatment group: positive control
Tramadol Hydrochloride SR Tablets
Tramadol Hydrochloride SR Tablets
Tramadol Hydrochloride SR Tablets
Interventions
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HRS-2129
HRS-2129
HRS-2129 placebo
HRS-2129 placebo
Tramadol Hydrochloride SR Tablets
Tramadol Hydrochloride SR Tablets
Eligibility Criteria
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Inclusion Criteria
2. Subjects requiring elective orthopedic surgery
3. Conform to the ASA Physical Status Classification
Exclusion Criteria
2. Subjects with nervous system disease
3. Subjects with a history of mental illness
4. Subjects with abnormal liver and renal function
5. Subjects with poorly controlled hypertensive or hypotensive
6. QTc：\>450ms（male），\>470ms（female）
7. Subjects who screened positive for substance abuse
8. History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s)
9. The investigators determined that other conditions were inappropriate for participation in this clinical trial
18 Years
ALL
No
Sponsors
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Shandong Suncadia Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Countries
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Central Contacts
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Other Identifiers
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HRS-2129-103
Identifier Type: -
Identifier Source: org_study_id
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