PainPhase 2NCT06680466
A Phase Ⅱ Study to Evaluate the Efficacy and Safety of YZJ-4729 in Patients With Moderate to Severe Acute Pain After Abdominal Surgery
A Phase 2 study testing YZJ-4729 and morphine in people with Pain, run by Shanghai Haiyan Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
Primary Objective： To explore the analgesic efficacy of YZJ-4729 compared with placebo in patients with acute postoperative pain following abdominal surgery. Secondary Objective： To explore the analgesic efficacy and safety of YZJ-4729 compared with placebo and morphine in patients with acute postoperative pain… 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 morphine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 179 participants
- Where
- 1 siteChina
- Study dates
- 26 Dec 2023to 8 Aug 2024
- 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
- Age≥18 and ≤75 years at screening.
- 18.0 kg/m2≤Body mass index (BMI) ≤28.0 kg/m2
- American Society of Anesthesiologists (ASA) Physical Status Classification System classification Ⅰ or Ⅱ.
- Scheduled to undergo abdominal surgery, and estimated duration of the surgery is between 1 hour and 6 hours.
- NRS ≥ 4 within 4 hours after after extubation of the tracheal tube.
- Able to understand and comply with the study procedures and requirements, and able to provide written informed consent before any study procedure
Who cannot join
- Individuals with a known history of allergy to any component of the investigational drug, or with an allergy or contraindication to anesthetic/analgesic drugs used during surgery;
- Patients with the following conditions or medical histories:
- Comorbid with stroke, Parkinson's syndrome, cognitive impairment, or a history of epilepsy (excluding convulsions caused by high fever in childhood),
- Patients with craniocerebral injury, increased intracranial pressure, or brain tumors,
- History of difficult airway, obstructive sleep apnea syndrome, bronchial asthma, chronic respiratory system diseases, other severe respiratory system diseases, or acute upper respiratory tract infections within 2 weeks;
- History of myocardial infarction or angina within 6 months before screening, or history of severe arrhythmias such as Ⅱ or higher degree atrioventricular block, with a history of New York Heart Association (NYHA) heart function classification class II or above;
Show all 30Show fewer
- History of vestibular dysfunction or motion sickness, or dizziness, nausea, dry retching/vomiting within 1 week before screening;
- Comorbid with gastrointestinal system motility disorders (such as reflux esophagitis) or known/suspected gastrointestinal obstruction, including paralytic gastrointestinal obstruction;
- Randomized blood glucose ≥11.1 mmol/L or glycated hemoglobin ≥9% during the screening period;
- Patients with a clear diagnosis of clinical hypothyroidism;
- Presence of other acute or chronic pain conditions before surgery or comorbid with other physical pain that could confound the evaluation of postoperative pain.
- Hypertension that has not received regular antihypertensive treatment or is poorly controlled despite treatment: during the screening period, systolic blood pressure greater than 160 mmHg, or diastolic blood pressure greater than 100 mmHg (excluding abnormalities during the peri-anesthetic period).
- Patients with a systolic blood pressure less than 90 mmHg during the screening period (excluding abnormalities during the peri-anesthetic period);
- Peripheral capillary oxygen saturation (SpO2) <92% in a non-oxygen-supplemented state (excluding abnormalities during the peri-anesthetic period) at screening;
- Clinically significantly abnormal electrocardiogram, including a QT interval corrected for heart rate (Fridericia; QTcF interval) of > 450 milliseconds in males and > 470 milliseconds in females, at screening.
- Abnormal liver or kidney function at cscreening: (total bilirubin > upper limit of normal [ULN], aspartate aminotransferase [AST] >1.5 × ULN AND alanine aminotransferase [ALT] >1.5 × ULN, or serum creatinine (Cr) level g >1.5 × ULN;
- Abnormal coagulation function: Prothrombin time (PT) prolonged by more than 3 seconds above the upper limit of normal and/or Activated Partial Thromboplastin Time (APTT) prolonged by more than 10 seconds above the upper limit of normal.
- Positive for Hepatitis B surface antigen (HBsAg), Hepatitis C virus antibodies (HCV-Ab), Treponema pallidum antibodies (for syphilis), and Human Immunodeficiency Virus antibodies (HIV-Ab).
- Use of medications that affect postoperative analgesic effects before randomization:
- Continuous use of opioid analgesics for more than 10 days for any reason within 3 months before randomization, or use of opioid analgesics within 5 half-lives before randomization (except permitted by the protocol);
- Use of the following medications within 5 half-lives before randomization (or, if half-life is unknown, within within 14 days), including but not limited to: ketamine, nonsteroidal anti-inflammatory drugs (NSAIDs, aspirin is allowed for cardiovascular event prevention, but it must have been stably used for at least 30 days before randomization, with a daily dose ≤100mg/day), alpha-2 adrenergic receptor agonists with analgesic/sedative effects (such as dexmedetomidine, clonidine), glucocorticoid drugs (excluding topical use), antiepileptic drugs, anxiolytics, antipsychotics, sedatives, or other medications that may affect pain assessment;
- Use of analgesic Chinese herbal medicines or traditional Chinese patent medicines within 7 days before randomization.
- Use of monoamine oxidase inhibitors (such as phenelzine, tranylcypromine, selegiline, pargyline, methamphetamine, etc.), selective serotonin reuptake inhibitors (SSRIs), selective serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, or triptans within 14 days before randomization.
- Use of moderate to severe inhibitors/inducers of the liver metabolic enzyme CYP3A4 within 14 days before randomization (such as: enzyme inhibitors - amiodarone, atazanavir, ketoconazole, clarithromycin, itraconazole, etc., enzyme inducers - rifampin, phenytoin sodium, phenobarbital, carbamazepine, etc.).
- Participated in any clinical trial involving medication (excluding vitamins and minerals) within 3 months prior to screening, except those not involving investigational drugs;
- History of drug abuse, alcohol poisoning/dependence, or drug misuse within 2 years prior to screening, or those with a positive urine drug screen during the screening period;
- Women who are pregnant or breastfeeding;
- Individuals who plan to conceive, are unwilling or unable to use effective contraceptive measures from the screening period to 3 months after the last use of the investigational product, or those who plan to donate sperm/eggs or have plans for egg freezing;
- Subjects deemed unsuitable to participate in this clinical trial by the investigator.
- -
Trial locations and contacts
1 site in 1 country.
China1 site
The Third Xiangya Hospital of Central South University
Changsha, Hunan
About this study
Official title: A Multicenter, Ramdomized, Double-Blind, Dose-Regimen Finding, Placebo and Active-Controlled Phase Ⅱ Study to Evaluate the Efficacy and Safety of YZJ-4729 in Patients With Moderate to Severe Acute Pain After Abdominal Surgery
Primary Objective： To explore the analgesic efficacy of YZJ-4729 compared with placebo in patients with acute postoperative pain following abdominal surgery.
Secondary Objective： To explore the analgesic efficacy and safety of YZJ-4729 compared with placebo and morphine in patients with acute postoperative pain following abdominal surgery.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YZJ-4729Drug
Dose Group 1
morphineDrug
morphine,
placeboDrug
placebo
YZJ-4729Drug
Dose Group 2
YZJ-4729Drug
Dose Group 3
YZJ-4729Drug
Dose Group 4
| Study group | Role | What they receive |
|---|---|---|
| Treatment group 1 | Experimental | Not described Receives: Drug: YZJ-4729 |
| Treatment group 2 | Experimental | Not described Receives: Drug: YZJ-4729 |
| Treatment group 3 | Experimental | Not described Receives: Drug: YZJ-4729 |
| Treatment group 4 | Experimental | Not described Receives: Drug: YZJ-4729 |
| Morphine | Active comparator | Not described Receives: Drug: morphine |
| Placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time-weighted sum of differences in resting state pain intensity over 24 hours (SPID24)
Measured: 24 hours
Secondary outcomes (4)
The proportion of subjects who did not use rescue analgesics within 0 to 24 hours
Measured: 0~24 hours
The time-weighted sum of differences in resting state pain intensity over different perioid
Measured: 0-24 hours
Participant ' satisfaction score for analgesia treatment
Measured: 24 hours
Investigator satisfaction score for analgesia treatment
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 posted8 Nov 2024
- Study start26 Dec 2023
- Primary completion15 Jul 2024
- Study completion8 Aug 2024
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
- Model description
- Multi center, randomized, double-blind, placebo-controlled, and positive drug parallel controls
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 179 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
- NCT06680466
- Sponsor's protocol ID
- YZJ-4729-2-01
- Status last verified
- Jun 2026
- First submitted
- 1 Nov 2024
- 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 Multicenter, Ramdomized, Double-Blind, Dose-Regimen Finding, Placebo and Active-Controlled Phase Ⅱ Study to Evaluate the Efficacy and Safety of YZJ-4729 in Patients With Moderate to Severe Acute Pain After Abdominal Surgery
- ClinicalTrials.gov ID
- NCT06680466
- Acronym / sponsor ID
- YZJ-4729-2-01
- Conditions
- Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Shanghai Haiyan Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Dec 2023 (actual)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 8 Aug 2024 (actual)
- First posted
- 8 Nov 2024 (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.
Primary Objective： To explore the analgesic efficacy of YZJ-4729 compared with placebo in patients with acute postoperative pain following abdominal surgery.
Secondary Objective： To explore the analgesic efficacy and safety of YZJ-4729 compared with placebo and morphine 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
- 6
- Model description
- Multi center, randomized, double-blind, placebo-controlled, and positive drug parallel controls
| Arm | Type | Receives |
|---|---|---|
| Treatment group 1 | Experimental | Drug: YZJ-4729 |
| Treatment group 2 | Experimental | Drug: YZJ-4729 |
| Treatment group 3 | Experimental | Drug: YZJ-4729 |
| Treatment group 4 | Experimental | Drug: YZJ-4729 |
| Morphine | Active comparator | Drug: morphine |
| Placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age≥18 and ≤75 years at screening.
- 18.0 kg/m2≤Body mass index (BMI) ≤28.0 kg/m2
- American Society of Anesthesiologists (ASA) Physical Status Classification System classification Ⅰ or Ⅱ.
- Scheduled to undergo abdominal surgery, and estimated duration of the surgery is between 1 hour and 6 hours.
- NRS ≥ 4 within 4 hours after after extubation of the tracheal tube.
Key exclusion criteria (30 listed)
- Individuals with a known history of allergy to any component of the investigational drug, or with an allergy or contraindication to anesthetic/analgesic drugs used during surgery;
- Patients with the following conditions or medical histories:
- Hypertension that has not received regular antihypertensive treatment or is poorly controlled despite treatment: during the screening period, systolic blood pressure greater than 160 mmHg, or diastolic blood pressure greater than 100 mmHg (excluding abnormalities during the peri-anesthetic period).
- Patients with a systolic blood pressure less than 90 mmHg during the screening period (excluding abnormalities during the peri-anesthetic period);
- Peripheral capillary oxygen saturation (SpO2) <92% in a non-oxygen-supplemented state (excluding abnormalities during the peri-anesthetic period) at screening;
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-4729Dose Group 1 | Drug | Treatment group 1 |
| morphinemorphine, | Drug | Morphine |
| placeboplacebo | Drug | Placebo |
| YZJ-4729Dose Group 2 | Drug | Treatment group 2 |
| YZJ-4729Dose Group 3 | Drug | Treatment group 3 |
| YZJ-4729Dose Group 4 | Drug | Treatment group 4 |
Primary outcome
The time-weighted sum of differences in resting state pain intensity over 24 hours (SPID24)
Time frame: 24 hours
4 secondary outcomes
The proportion of subjects who did not use rescue analgesics within 0 to 24 hours
Time frame: 0~24 hours
The time-weighted sum of differences in resting state pain intensity over different perioid
Time frame: 0-24 hours
Participant ' satisfaction score for analgesia treatment
Time frame: 24 hours
Investigator satisfaction score for analgesia treatment
Time frame: 24 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
Digital Use, 24-Hour Movement Behaviors, and Myofascial Release in University Students With Neck Pain
Forward Head Posture, Chronic Nonspecific Neck Pain
Recruiting
Effects of Virtual Reality Exergames Versus Spinal Manipulation in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low-back Pain, CNSLBP
Recruiting
Dietary Intervention for Migraine Relief
Migraine
RecruitingPhase 4
Anrikefon-based Patient-controlled Intravenous Analgesia Following Laparoscopic Surgery
Laparoscopic Surgery, Visceral Pain, Postoperative
Not yet recruiting
Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
Adenomyosis, Adenomyoma of Uterus
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.
1 site 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 morphine in people with Pain, run by Shanghai Haiyan Pharmaceutical Technology Co., Ltd. at 1 site 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 6 inclusion and 30 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 1 site 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 time-weighted sum of differences in resting state pain intensity over 24 hours (SPID24) (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.