Clinical Study of HRS-2129 for Postoperative Analgesia in Orthopaedics

Shandong Suncadia Medicine

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Postoperative Pain in Orthopaedics

Treatments: Drug: HRS-2129 placebo; Drug: HRS-2129; Drug: Tramadol Hydrochloride SR Tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT06780267

HRS-2129-103

Details and patient eligibility

About

The study is being conducted to evaluate the safety, and efficacy of HRS-2129 for Postoperative analgesia in orthopaedics. To explore the reasonable dosage of HRS-2129 for Postoperative analgesia in orthopaedics.

Enrollment: 195 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Able and willing to provide a written informed consent
2. Subjects requiring elective orthopedic surgery
3. Conform to the ASA Physical Status Classification

Exclusion criteria

1. Subjects with a history of severe allergies
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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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195 participants in 3 patient groups

Treatment group: low\middle\high-dose

Experimental group

Description:

HRS-2129； HRS-2129 placebo

Treatment:

Drug: HRS-2129

Drug: HRS-2129 placebo

Treatment group:placebo

Experimental group

Description:

HRS-2129 placebo

Treatment:

Drug: HRS-2129 placebo

Treatment group: positive control

Active Comparator group

Description:

Tramadol Hydrochloride SR Tablets

Treatment:

Drug: Tramadol Hydrochloride SR Tablets