Pain, PostoperativePhase 2NCT06467409
Phase II Clinical Trial to Evaluate the Efficacy and Safety of LPM3480392 Injection for Moderate to Severe Pain After Orthopedic Surgery
A Phase 2 study testing morphine hydrochloride injection and LPM3480392 Injection in people with Pain, Postoperative, run by Luye Pharma Group Ltd. at 1 site in China.
Trial summary
A randomized, double-blind, placebo/positive drug parallel controlled design was used to evaluate the preliminary efficacy and safety of intravenous infusion of LPM3480392 injection using different dosing regimens in subjects with moderate to severe pain after Orthopedic surgery Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- morphine hydrochloride injection and LPM3480392 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 26 Jan 2024to Jan 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily signed informed consent form (ICF) and comply with the trial procedures before starting the trial-related activities;
- Over 18 years old , male or female;
- Body mass index (BMI) 18-28 kg/m2 (including the boundary value)；
- Subjects who plan to undergo unilateral total knee replacement or unilateral knee ligament reconstruction under general anesthesia; ;
- American Society of Anesthesiologists(ASA )grade I ~ II;
- Female subjects with a negative pregnancy test at Screening. Male and female subjects agree to take effective contraceptive measures throughout the study and for at least 1 month after medication;
- the numerical rating scale(NRS) score at rest was ≥ 4 points within 4 hours after surgery.
Who cannot join
- Known history of allergy to any component of the investigational product, or allergy or contraindication to the anesthetic/analgesic drugs used in the study;
- Had any of the following conditions or medical history:
- History of stroke, cognitive dysfunction, or epilepsy (excluding convulsions caused by previous febrile convulsions in children);
- History of difficult airway, such as obstructive sleep apnea syndrome, bronchial asthma, chronic respiratory diseases or other serious respiratory diseases;
- Subjects with a history of myocardial infarction, angina pectoris, severe arrhythmia of degree II or above atrioventricular block, or New York Heart Association(NYHA) Class II or above within 6 months prior to screening;
- History of vestibular dysfunction or motion sickness;
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- Have a history of diabetes and glycosylated hemoglobin ≥ 9% during the screening period;
- Esophagitis;
- Paralytic gastrointestinal obstruction;
- The presence of other acute and chronic pain conditions preoperatively or in combination with other bodily pain conditions that confound the evaluation of postoperative pain.
- Medications affecting postoperative analgesia before randomization ：
- Opioid analgesics taken continuously for more than 10 days for any reason within 3 months prior to randomization, or taking drugs that involving analgesia prior to randomization and The time from last drug use to randomization is less than 5 half-lives( in accord with label ; unless t1/2 is unkown，execute according to 48h ) ,including but not limited to: ketamine, non-steroidal anti-inflammatory drugs (aspirin, acetaminophen, indomethacin, diclofenac, ibuprofen, parecoxib sodium, etc.), alpha adrenoceptor agonists (dexmedetomidine hydrochloride, clonidine, etc.), glucocorticoids (dexamethasone hydrochloride, hydrocortisone, methylprednisolone, etc., except for topical or topical use of glucocorticoids), antiepileptic drugs (carbamazepine, sodium valproate, etc.), sedative drugs (diazepam, estazolam, midazolam, alprazolam, barbiturate, phenobarbital and chloral hydrate, etc.); b. Use of Chinese herbal medicine or Chinese patent medicine which has the function of analgesia, sedation, antiemetic within 48h prior to randomization.
- Systolic blood pressure less than 90 mmHg or greater than 160 mmHg and diastolic blood pressure 60 mmHg or greater in screening phase;
- oxygen saturation by pulse oximetry(SpO2) < 92% at screening ;
- Corrected QT interval(QTc )> 450 ms for males and > 460 m for females at screening ;
- Patients with abnormal liver and kidney function during screening period:alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 1.5 times of normal value, total bilirubin higher than the upper limit of normal value, serum creatinine (Cr) > 1.5 times of the upper limit of normal value during screening period;
- Subjects with coagulation abnormalities (PT prolonged more than 3 seconds above the upper limit of normal and/or activated partial thromboplastin time(APTT) prolonged more than 10 seconds above the upper limit of normal) during the screening period; and the investigator confirmed that the abnormalities were clinically significant;
- History of drug abuse or drug abuse before screening;
- Positive result in screening of drugs of abuse via urinalysis;
- Lactating mothers;
- hepatitis C virus (HCV) antibody, treponema pallidum antibody, human immunodeficiency virus (HIV) antibody positive ;
- Participation in any medication (excluding vitamins and minerals) within 3 months prior to informed consent Quality) Clinical trial personnel, except for those not using investigational drugs;
- subjects who are judged by the investigator to be not suitable for this clinical trial, including but not limited to the presence of conditions that may confound the interpretation of efficacy, safety, or tolerability data in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Wuhan
xiangdong chen
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo, Positive Drug Parallel Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of LPM3480392 Injection for Moderate to Severe Pain After Orthopedic Surgery
A randomized, double-blind, placebo/positive drug parallel controlled design was used to evaluate the preliminary efficacy and safety of intravenous infusion of LPM3480392 injection using different dosing regimens in subjects with moderate to severe pain after Orthopedic surgery
- Conditions
- Pain, Postoperative
- Being tested
- Placebo, morphine hydrochloride injection, LPM3480392 Injection
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
patient-controlled analgesia(PCA) administration
morphine hydrochloride injectionDrug
patient-controlled analgesia(PCA) administration
LPM3480392 InjectionDrug
patient-controlled analgesia(PCA) administration
LPM3480392 InjectionDrug
patient-controlled analgesia(PCA) administration
LPM3480392 InjectionDrug
patient-controlled analgesia(PCA) administration
LPM3480392 InjectionDrug
patient-controlled analgesia(PCA) administration
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| morphine hydrochloride injection | Active comparator | Not described Receives: Drug: morphine hydrochloride injection |
| LPM3480392 injection group 1 | Experimental | Not described Receives: Drug: LPM3480392 Injection |
| LPM3480392 injection group 2 | Experimental | Not described Receives: Drug: LPM3480392 Injection |
| LPM3480392 injection group 3 | Experimental | Not described Receives: Drug: LPM3480392 Injection |
| LPM3480392 injection group4 | Experimental | Not described Receives: Drug: LPM3480392 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
SPID48
the Sum of Pain Intensity Differences in Pain Score from baseline Over 48 Hours
Measured: 48 hours
Secondary outcomes (2)
Cumulative dose of rescue analgesic drugs
Measured: 48 hours
Incidence of adverse events
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 posted21 Jun 2024
- Study start26 Jan 2024
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Luye Pharma Group Ltd.The sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luye Pharma Group Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06467409
- Sponsor's protocol ID
- LY03014/CT-CHN-204
- Status last verified
- Jun 2024
- First submitted
- 26 Jan 2024
- Last updated
- 21 Jun 2024
- 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 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo, Positive Drug Parallel Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of LPM3480392 Injection for Moderate to Severe Pain After Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT06467409
- Acronym / sponsor ID
- LY03014/CT-CHN-204
- Conditions
- Pain, Postoperative
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Luye Pharma Group Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Jan 2024 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 21 Jun 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.
A randomized, double-blind, placebo/positive drug parallel controlled design was used to evaluate the preliminary efficacy and safety of intravenous infusion of LPM3480392 injection using different dosing regimens in subjects with moderate to severe pain after Orthopedic surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| morphine hydrochloride injection | Active comparator | Drug: morphine hydrochloride injection |
| LPM3480392 injection group 1 | Experimental | Drug: LPM3480392 Injection |
| LPM3480392 injection group 2 | Experimental | Drug: LPM3480392 Injection |
| LPM3480392 injection group 3 | Experimental | Drug: LPM3480392 Injection |
| LPM3480392 injection group4 | Experimental | Drug: LPM3480392 Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Voluntarily signed informed consent form (ICF) and comply with the trial procedures before starting the trial-related activities;
- Over 18 years old , male or female;
- Body mass index (BMI) 18-28 kg/m2 (including the boundary value)；
- Subjects who plan to undergo unilateral total knee replacement or unilateral knee ligament reconstruction under general anesthesia; ;
- American Society of Anesthesiologists(ASA )grade I ~ II;
Key exclusion criteria (23 listed)
- Known history of allergy to any component of the investigational product, or allergy or contraindication to the anesthetic/analgesic drugs used in the study;
- Had any of the following conditions or medical history:
- Medications affecting postoperative analgesia before randomization ：
- Systolic blood pressure less than 90 mmHg or greater than 160 mmHg and diastolic blood pressure 60 mmHg or greater in screening phase;
- oxygen saturation by pulse oximetry(SpO2) < 92% 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 |
|---|---|---|
| Placebopatient-controlled analgesia(PCA) administration | Drug | Placebo |
| morphine hydrochloride injectionpatient-controlled analgesia(PCA) administration | Drug | morphine hydrochloride injection |
| LPM3480392 Injectionpatient-controlled analgesia(PCA) administration | Drug | LPM3480392 injection group 1 |
| LPM3480392 Injectionpatient-controlled analgesia(PCA) administration | Drug | LPM3480392 injection group 2 |
| LPM3480392 Injectionpatient-controlled analgesia(PCA) administration | Drug | LPM3480392 injection group 3 |
| LPM3480392 Injectionpatient-controlled analgesia(PCA) administration | Drug | LPM3480392 injection group4 |
Primary outcome
SPID48
Time frame: 48 hours
the Sum of Pain Intensity Differences in Pain Score from baseline Over 48 Hours
2 secondary outcomes
Cumulative dose of rescue analgesic drugs
Time frame: 48 hours
Incidence of adverse events
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
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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.
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 morphine hydrochloride injection and LPM3480392 Injection in people with Pain, Postoperative, run by Luye Pharma Group 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 7 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 21 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact xiangdong chen (15071096621, xiangdongchen2013@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SPID48 (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 21 Jun 2024.