A Study of YZJ-4729 Tartrate Injection for the Treatment of Pain After Abdominal Surgery

Phase 3

Not yet recruiting

• Conditions: Pain

• Registration Number: NCT06890533
• Lead 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 abdominal surgery.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-11
• Study First Submitted QC: 2025-03-21
• Last Update Submitted: 2025-03-21
• Study First Posted: 2025-03-24
• Last Update Posted: 2025-03-24
• Study Start: 2025-04
• Primary Completion: 2026-06
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 560

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. Body mass index (BMI) ≥18 kg/m2 and ≤28 kg/m2.
3. ASA I - II
4. Experiences a pain intensity rating of moderate to severe acute pain following abdominal surgery, with a pain intensity score of ≥4 on a Numeric Rating Scale (NRS) within 4 hours post-surgery

Exclusion Criteria

1. Allergy to opioids and other medications that may be used during the trial.
2. Nervous system disorders (e.g. epilepsy)
3. Psychiatric disorders (e.g. depression)
4. History of difficult airways
5. Random blood glucose ≥11.1 mmol/L
6. Uncontrolled blood pressure [e.g., hypertension (systolic blood pressure ≥160 mmHg, diastolic blood pressure ≥100 mmHg)，or hypotension(systolic blood pressure <90 mmHg)]
7. Abnormal pulse oxygen saturation (SpO2 <90 %)
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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
the Sum of Pain Intensity Differences Over 24 Hours at rest	24 hours	Pain intensity will be evaluated using an 11-point (0-10) Numeric Pain Rating Scale (NRS), with higher numbers indicating a higher pain intensity, administered over 24 hours.

Secondary Outcome Measures

Name	Time	Method
The proportion of subjects using rescue analgesics	24 hours
The number of times for rescue analgesics using	24 hours
The cumulative dose used of rescue analgesics	24 hours
the resting Sum of Pain Intensity Differences Over 6、12、18、12-24 Hours	24 hours
the active Sum of Pain Intensity Differences Over 6、12、18、24、12-24 Hours	24 hours
Participant satisfaction scores for analgesia treatment	24 hours	Participants recalled the postoperative analgesia effect and rated their satisfaction on a scale of 1 to 5, with 1 representing dissatisfied and 5 representing very satisfied.
Investigator satisfaction scores for analgesia treatment	24 hours	Postoperative analgesia was evaluated by investigators. The scale ranges from 1 to 5, with 1 being dissatisfied and 5 being very satisfied.
The Time to first using rescue analgesics	24 hours

Trial Locations

Locations (49)

Cangzhou Central Hospital; 🇨🇳 Cangzhou, China

Cangzhou People's Hospital; 🇨🇳 Cangzhou, China

The First Hospital of Jilin University; 🇨🇳 Ch'ang-ch'un, China

Changde First People's Hospital; 🇨🇳 Changde, China

Changsha Hospital Affiliated to Hunan University; 🇨🇳 Changsha, China

The Fourth Hospital OF Changsha; 🇨🇳 Changsha, China

The Third Xiangya Hospital of Central South University; 🇨🇳 Changsha, China

Sichuan Provincial People's Hospital; 🇨🇳 Chengdu, China

The Second People's Hospital of Chengdu; 🇨🇳 Chengdu, China

The Third People's Hospital of Chengdu; 🇨🇳 Chengdu, China

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