PainPhase 3NCT06890533
A Study of YZJ-4729 Tartrate Injection for the Treatment of Pain After Abdominal Surgery
A Phase 3 study testing Experimental: YZJ-4729 and Active Comparator: Morphine in people with Pain, run by Shanghai Haiyan Pharmaceutical Technology Co., Ltd. at 49 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain
- What is being tested?
- Experimental: YZJ-4729 and Active Comparator: Morphine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 560 participants
- Where
- 49 sitesChina
- Study dates
- 14 May 2025to Sep 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be able to understand the study purpose and cooperate with the study procedures of this trial, voluntarily provide written informed consent
- Body mass index (BMI) ≥18 kg/m2 and ≤28 kg/m2.
- ASA I - II
- 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
Who cannot join
- Allergy to opioids and other medications that may be used during the trial.
- Nervous system disorders (e.g. epilepsy)
- Psychiatric disorders (e.g. depression)
- History of difficult airways
- Random blood glucose ≥11.1 mmol/L
- Uncontrolled blood pressure [e.g., hypertension (systolic blood pressure ≥160 mmHg, diastolic blood pressure ≥100 mmHg)，or hypotension(systolic blood pressure <90 mmHg)]
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- Abnormal pulse oxygen saturation (SpO2 <90 %)
- Abnormal liver function or renal function
- Used agents that could affect the analgesic response
- Used agents that could affect drug metabolism
- Has previously participated in another YZJ-4729 clinical study
Trial locations and contacts
49 sites in 1 country.
49 sites in 1 country
China49 sites
Cangzhou Central Hospital
Cangzhou
Cangzhou People's Hospital
Cangzhou
The First Hospital of Jilin University
Ch’ang-ch’un
Changde First People's Hospital
Changde
Changsha Hospital Affiliated to Hunan University
Changsha
The Fourth Hospital OF Changsha
Changsha
The Third Xiangya Hospital of Central South University
Changsha
Sichuan Provincial People's Hospital
Chengdu
The Second People's Hospital of Chengdu
Chengdu
The Third People's Hospital of Chengdu
Chengdu
The First Affiliated Hospital of Chongqing Medical University
Chongqing
The Second Affiliated Hospital of Chongqing Medical University
Chongqing
Affiliated Zhongshan Hospital of Dalian University
Dalian
Deyang People's Hospital
Deyang
Dongguan People's Hospital
Dongguan
Ganzhou People's Hospital
Ganzhou
The First People's Hospital of Guangyuan
Guangyuan
Guangdong Province Traditional Chinese Medical Hospital
Guangzhou
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou
The First Affiliated Hospital of Jinan University
Guangzhou
The Fourth Affiliated Hospital of Harbin Medical University
Ha’erbin
Haikou People's Hospital
Haikou
The Second People's Hospital of Hefei
Hefei
The First Affiliated Hospital of University of South China
Hengyang
Huzhou Central Hospital
Huzhou
The First Hospital of Jiaxing
Jiaxing
Liuzhou People's Hospital
Liuzhou
Liuzhou Workers' Hospital
Liuzhou
Luoyang Central Hospital
Luoyang
Ma'anshan People's Hospital
Ma’anshan
Mianyang Central Hospital
Mianyang
JiangXi Provincial People's Hospital
Nanchang
The Second Nanning People's Hospital
Nanning
The Second People's Hospital of Neijiang
Neijiang
Ningbo Medical Center Lihuili Hospital
Ningbo
Qingdao Central Hospital of Rehabilitation University
Qingdao
Shanghai First Maternity and Infant Hospital
Shanghai
Shanghai Fourth People's Hospital
Shanghai
Taizhou People's Hospital
Taizhou
The Second Hospital of Tianjin Medical University
Tianjin
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Wuhan Third Hospital
Wuhan
Affiliated Hospital of Jiangnan University
Wuxi
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an
Zhongshan Hospital Xiamen University
Xiamen
The Second People's Hospital of Yibin
Yibin
Zhangzhou Municipal of Fujian Province
Zhangzhou
Henan Provincial People's Hospital
Zhengzhou
Zhuzhou Central Hospital
Zhuzhou
About this study
Official title: A Phase Ⅲ, Randomized, Double-Blind, Placebo- and Active-controlled Study of YZJ-4729 Tartrate Injection for the Treatment of Moderate to Severe Pain After Abdominal Surgery
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.
- Conditions
- Pain
- Being tested
- Experimental: YZJ-4729, Placebo Comparator: Saline, Active Comparator: Morphine
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: YZJ-4729Drug
Loading dose + demand dose
Placebo Comparator: SalineDrug
Loading dose + demand dose
Active Comparator: MorphineDrug
Loading dose + demand dose
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group 1 | Experimental | Not described Receives: Drug: Experimental: YZJ-4729 |
| Experimental Group 2 | Experimental | Not described Receives: Drug: Experimental: YZJ-4729 |
| Placebo Comparator | Placebo comparator | Not described Receives: Drug: Placebo Comparator: Saline |
| Active Comparator | Active comparator | Not described Receives: Drug: Active Comparator: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Sum of Pain Intensity Differences Over 24 Hours at rest
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.
Measured: 24 hours
Secondary outcomes (8)
The Time to first using rescue analgesics
Measured: 24 hours
The proportion of subjects using rescue analgesics
Measured: 24 hours
The number of times for rescue analgesics using
Measured: 24 hours
The cumulative dose used of rescue analgesics
Measured: 24 hours
the resting Sum of Pain Intensity Differences Over 6、12、18、12-24 Hours
Measured: 24 hours
the active Sum of Pain Intensity Differences Over 6、12、18、24、12-24 Hours
Measured: 24 hours
Participant satisfaction scores for analgesia treatment
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.
Measured: 24 hours
Investigator satisfaction scores for analgesia treatment
Postoperative analgesia was evaluated by investigators. The scale ranges from 1 to 5, with 1 being dissatisfied and 5 being very satisfied.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start14 May 2025
- Primary completion17 Apr 2026
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Haiyan Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06890533
- Sponsor's protocol ID
- YZJ-4729-3-01
- Status last verified
- Jun 2026
- First submitted
- 11 Mar 2025
- Last updated
- 29 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅲ, Randomized, Double-Blind, Placebo- and Active-controlled Study of YZJ-4729 Tartrate Injection for the Treatment of Moderate to Severe Pain After Abdominal Surgery
- ClinicalTrials.gov ID
- NCT06890533
- Acronym / sponsor ID
- YZJ-4729-3-01
- Conditions
- Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- Shanghai Haiyan Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 May 2025 (actual)
- Primary completion
- 17 Apr 2026 (actual)
- Study completion
- Sep 2026 (estimated)
- First posted
- 24 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experimental Group 1 | Experimental | Drug: Experimental: YZJ-4729 |
| Experimental Group 2 | Experimental | Drug: Experimental: YZJ-4729 |
| Placebo Comparator | Placebo comparator | Drug: Placebo Comparator: Saline |
| Active Comparator | Active comparator | Drug: Active Comparator: Morphine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be able to understand the study purpose and cooperate with the study procedures of this trial, voluntarily provide written informed consent
- Body mass index (BMI) ≥18 kg/m2 and ≤28 kg/m2.
- ASA I - II
- 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
Key exclusion criteria (11 listed)
- Allergy to opioids and other medications that may be used during the trial.
- Nervous system disorders (e.g. epilepsy)
- Psychiatric disorders (e.g. depression)
- History of difficult airways
- Random blood glucose ≥11.1 mmol/L
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: YZJ-4729Loading dose + demand dose | Drug | Experimental Group 1, Experimental Group 2 |
| Placebo Comparator: SalineLoading dose + demand dose | Drug | Placebo Comparator |
| Active Comparator: MorphineLoading dose + demand dose | Drug | Active Comparator |
Primary outcome
the Sum of Pain Intensity Differences Over 24 Hours at rest
Time frame: 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.
8 secondary outcomes
The Time to first using rescue analgesics
Time frame: 24 hours
The proportion of subjects using rescue analgesics
Time frame: 24 hours
The number of times for rescue analgesics using
Time frame: 24 hours
The cumulative dose used of rescue analgesics
Time frame: 24 hours
the resting Sum of Pain Intensity Differences Over 6、12、18、12-24 Hours
Time frame: 24 hours
the active Sum of Pain Intensity Differences Over 6、12、18、24、12-24 Hours
Time frame: 24 hours
Participant satisfaction scores for analgesia treatment
Time frame: 24 hours
Investigator satisfaction scores for analgesia treatment
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
49 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Experimental: YZJ-4729 and Active Comparator: Morphine in people with Pain, run by Shanghai Haiyan Pharmaceutical Technology Co., Ltd. at 49 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Sum of Pain Intensity Differences Over 24 Hours at rest (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.