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NCT06780267 | NOT YET RECRUITING | Postoperative Pain in Orthopaedics


Clinical Study of HRS-2129 for Postoperative Analgesia in Orthopaedics
Sponsor:

Shandong Suncadia Medicine Co., Ltd.

Brief Summary:

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.

Condition or disease

Postoperative Pain in Orthopaedics

Intervention/treatment

HRS-2129

HRS-2129

HRS-2129 placebo

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 40 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : Clinical Study on Safety and Efficacy of HRS-2129 for Postoperative Analgesiain Orthopaedics
Actual Study Start Date : 2025-02-15
Estimated Primary Completion Date : 2025-06-30
Estimated Study Completion Date : 2025-06-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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

Clinical Study of HRS-2129 for Postoperative Analgesia in Orthopaedics

Location Details

NCT06780267


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Locations


Not yet recruiting

China, Sichuan

Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital

Chengdu, Sichuan, China, 610072

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