PainPhase 2NCT06901830
A Study of YZJ-4729 Tartrate Injection for the Treatment of Pain After Orthopedic Surgery
A Phase 2 study testing YZJ-4729 and Active Comparator: Morphine in people with Pain, run by Shanghai Haiyan Pharmaceutical Technology Co., Ltd. at 21 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 Orthopedic 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?
- YZJ-4729 and Active Comparator: Morphine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 21 sitesChina
- Study dates
- 23 May 2025to 18 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- BMI≥18.0 kg/m2 and ≤28.0 kg/m2
- ASA I to II
- 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
Who cannot join
- Opioid allergy
- Nervous system diseases (e.g. epilepsy)
- Psychiatric disorders (e.g. depression)
- History of difficult airways
- Random blood glucose ≥11.1 mmol/L
- Subjects with systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg or systolic blood pressure < 90 mmHg
Show all 11Show fewer
- Abnormal pulse oxygen saturation (SpO2 <92 %)
- 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
21 sites in 1 country.
21 sites in 1 country
China21 sites
The First Hospital of Jilin University
Ch’ang-ch’un
The Third Xiangya Hospital of Central South University
Changsha
Chengdu Second People's Hospital
Chengdu
Sichuan Provincial People's Hospital
Chengdu
The Third People's Hospital of Chengdu
Chengdu
Dalian University Affiliated Zhongshan Hospital
Dalian
Dongguan People's Hospital
Dongguan
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou
The Second People's Hospital of Hefei
Hefei
Jinhua Central Hospital
Jinhua
Mianyang Central Hospital
Mianyang
The First Affiliated Hospital of Nanchang University
Nanchang
Zhongda Hospital Southeast University
Nanjing
Ningbo Medical Center Lihuili Hospital
Ningbo
The First Affiliated Hospital of Ningbo University
Ningbo
The Second Affiliated Hospital of Fujian Medical University
Quanzhou
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai
Shanghai First People's Hospital
Shanghai
The Third Hospital of Hebei Medical University
Shijiazhuang
Suzhou University Affiliated Second Hospital
Suzhou
Henan Provincial People's Hospital
Zhengzhou
About this study
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
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
- Conditions
- Pain
- Being tested
- 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.
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: YZJ-4729 |
| Experimental Group 2 | Experimental | Not described Receives: Drug: YZJ-4729 |
| Experimental Group 3 | Experimental | Not described Receives: Drug: 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 in pain score over 48 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 48 hours.
Measured: 48 hours
Secondary outcomes (8)
The time of first using of rescue analgesics
Measured: 0-48 hours
The proportion of subjects using rescue analgesics
Measured: 0-48 hours
The number of times for rescue analgesics using
Measured: 0-48 hours
The cumulative dose used of rescue analgesics
Measured: 0-48 hours
The resting Sum of Pain Intensity Differences Over 12,24,24~48
Measured: 0-48 hours
The active Sum of Pain Intensity Differences Over 12,24,48,24~48
Measured: 0-48 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: 48 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: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start23 May 2025
- Primary completion6 Dec 2025
- Study completion18 Dec 2025
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
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
- NCT06901830
- Sponsor's protocol ID
- YZJ-4729-2-02
- Status last verified
- Jun 2026
- First submitted
- 24 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 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
- ClinicalTrials.gov ID
- NCT06901830
- Acronym / sponsor ID
- YZJ-4729-2-02
- Conditions
- Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Shanghai Haiyan Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 May 2025 (actual)
- Primary completion
- 6 Dec 2025 (actual)
- Study completion
- 18 Dec 2025 (actual)
- First posted
- 30 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 Orthopedic surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Experimental Group 1 | Experimental | Drug: YZJ-4729 |
| Experimental Group 2 | Experimental | Drug: YZJ-4729 |
| Experimental Group 3 | Experimental | Drug: 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
- BMI≥18.0 kg/m2 and ≤28.0 kg/m2
- ASA I to II
- 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
Key exclusion criteria (11 listed)
- Opioid allergy
- Nervous system diseases (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 |
|---|---|---|
| YZJ-4729Loading dose + demand dose | Drug | Experimental Group 1, Experimental Group 2, Experimental Group 3 |
| 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 in pain score over 48 hours at rest
Time frame: 48 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 48 hours.
8 secondary outcomes
The time of first using of rescue analgesics
Time frame: 0-48 hours
The proportion of subjects using rescue analgesics
Time frame: 0-48 hours
The number of times for rescue analgesics using
Time frame: 0-48 hours
The cumulative dose used of rescue analgesics
Time frame: 0-48 hours
The resting Sum of Pain Intensity Differences Over 12,24,24~48
Time frame: 0-48 hours
The active Sum of Pain Intensity Differences Over 12,24,48,24~48
Time frame: 0-48 hours
Participant satisfaction scores for analgesia treatment
Time frame: 48 hours
Investigator satisfaction scores for analgesia treatment
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing YZJ-4729 and Active Comparator: Morphine in people with Pain, run by Shanghai Haiyan Pharmaceutical Technology Co., Ltd. at 21 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: finished, 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 21 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 in pain score over 48 hours at rest (time frame: 48 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.