Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06901830 | NOT YET RECRUITING | Pain

A Study of YZJ-4729 Tartrate Injection for the Treatment of Pain After Orthopedic Surgery
Sponsor:

Shanghai Haiyan Pharmaceutical Technology Co., Ltd.

Brief Summary:

The primary objective is to evaluate the analgesic efficacy and safety of IV YZJ-4729 Tartrate Injection in patients with acute postoperative pain following Orthopedic surgery

Condition or disease

Pain

Intervention/treatment

YZJ-4729

Placebo Comparator: Saline

Active Comparator: Morphine

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 150 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : A PhaseⅡ, Randomized, Double-Blind, Placebo- and Active- Controlled Study of YZJ-4729 Tartrate Injection for the Treatment of Moderate to Severe Pain After Orthopedic Surgery
Actual Study Start Date : 2025-04
Estimated Primary Completion Date : 2025-10
Estimated Study Completion Date : 2025-11

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Be able to understand the study purpose and cooperate with the study procedures of this trial, voluntarily provide written informed consent
  • 2. BMI≥18.0 kg/m2 and ≤28.0 kg/m2
  • 3. ASA I to II
  • 4. Experiences a pain intensity rating of moderate to severe acute pain following orthopedic surgery, with a pain intensity score of ≥4 on a Numeric Rating Scale (NRS) within 4 hours post-surgery
Exclusion Criteria
  • 1. Opioid allergy
  • 2. Nervous system diseases (e.g. epilepsy)
  • 3. Psychiatric disorders (e.g. depression)
  • 4. History of difficult airways
  • 5. Random blood glucose ≥11.1 mmol/L
  • 6. Subjects with systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>100 mmHg or systolic blood pressure \< 90 mmHg
  • 7. Abnormal pulse oxygen saturation (SpO2 \<92 %)
  • 8. Abnormal liver function or renal function
  • 9. Used agents that could affect the analgesic response
  • 10. Used agents that could affect drug metabolism
  • 11. Has previously participated in another YZJ-4729 clinical study
A Study of YZJ-4729 Tartrate Injection for the Treatment of Pain After Orthopedic Surgery

Location Details

NCT06901830

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

China,

The First Hospital of Jilin University

Ch'Ac-ch'un, China,

Not yet recruiting

China,

The Third Xiangya Hospital of Central South University

Changsha, China,

Not yet recruiting

China,

Chengdu Second People's Hospital

Chengdu, China,

Not yet recruiting

China,

Sichuan Provincial People's Hospital

Chengdu, China,

Not yet recruiting

China,

The Third People's Hospital of Chengdu

Chengdu, China,

Not yet recruiting

China,

Dalian University Affiliated Zhongshan Hospital

Dalian, China,

Not yet recruiting

China,

Dongguan People's Hospital

Dongguan, China,

Not yet recruiting

China,

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, China,

Not yet recruiting

China,

The Second People's Hospital of Hefei

Fairy, China,

Not yet recruiting

China,

Jinhua Central Hospital

Jinhua, China,

Not yet recruiting

China,

Wed a Central hospital

Mianyang, China,

Not yet recruiting

China,

The First Affiliated Hospital of Nanchang University

Nanchang, China,

Not yet recruiting

China,

Zhongda Hospital Southeast University

Nanjing, China,

Not yet recruiting

China,

Ningbo Medical Center Lihuili Hospital

Ningbo, China,

Not yet recruiting

China,

The First Affiliated Hospital of Ningbo University

Ningbo, China,

Not yet recruiting

China,

The Second Affiliated Hospital of Fujian Medical University

Quanzhou, China,

Not yet recruiting

China,

Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, China,

Not yet recruiting

China,

Shanghai First People's Hospital

Shanghai, China,

Not yet recruiting

China,

The Third Hospital of Hebei Medical University

Shijiazhuang, China,

Not yet recruiting

China,

Suzhou University Affiliated Second Hospital

Suzhou, China,

Not yet recruiting

China,

Henan Provincial People's Hospital

Zhengzhou, China,