Pain, PostoperativePhase 2NCT06204120
Phase II Clinical Trial to Evaluate the Efficacy and Safety of LPM3480392 Injection for Moderate to Severe Pain After Abdominal Surgery
A Phase 2 study testing LPM3480392 Injection and morphine hydrochloride 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 abdominal surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- LPM3480392 Injection and morphine hydrochloride 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
- 25 Nov 2022to 4 Jul 2023
- 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 65 years
- 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;
- Aged 18-65 years (including the boundary value), male or female;
- Body mass index (BMI) 18-29 kg/m2 (including the boundary value), male body weight ≥ 50 kg; female body weight ≥ 45 kg;
- Subjects scheduled for elective abdominal surgery under general anesthesia, 1h ≤ duration of estimated surgery Interval ≤ 4h;
- American Society of Anesthesiologists（ASA ）grade I ~ II;
- Female subjects (not surgically sterile, surgical sterilization is defined as hysterectomy or oophorectomy) 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 investigator judges that the patient has recovered from intraoperative anesthesia to enough awake, which can be accurately completed the questionnaire was specified, and 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 opioid analgesics within 7 days prior to randomization; b） Use of the following drugs within 14 days prior to randomization, 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.); c） Use of Chinese herbal medicine or Chinese patent medicine within 7 days prior to randomization.
- Systolic blood pressure less than 90 mmHg or greater than 160 mmHg and diastolic blood pressure less than 1 day before surgery 60 mmHg or greater;
- Peripheral saturation (SpO2) < 92% at screening or before administration;
- corrected QT interval（QTc ）> 450 ms for males and > 460 m for females at screening or pre-dose ( QTc is expressed as Fridericia formula calculation);
- Patients with abnormal liver and kidney function during screening period or before administration: 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;
- Nursing mothers;
- Positive hepatitis B virus surface antigen (HBsAg) test [but the subject is eligible if the peripheral blood hepatitis B virus deoxyribonucleic acid (HBV DNA) is lower than the lower limit of the reference range, and the investigator believes that the subject is in a stable phase of chronic hepatitis B and will not increase the risk of the subject]; 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
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
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 Abdominal 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 abdominal surgery.
- Conditions
- Pain, Postoperative
- Being tested
- LPM3480392 Injection, Placebo, morphine hydrochloride 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.
LPM3480392 InjectionDrug
PCA administration
PlaceboDrug
PCA administration
morphine hydrochloride injectionDrug
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 group 4 | Experimental | Not described Receives: Drug: LPM3480392 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
SPID24(the Sum of Pain Intensity Differences in Pain Score from baseline Over 24 Hours)
Pain intensity will be evaluated using an 11-point (0-10) Numeric Pain Rating Scale (NPRS), with higher numbers indicating a higher pain intensity, administered over 24 hours.
Measured: one day
Secondary outcomes (7)
Cumulative dose of rescue analgesic drugs within 24 h
Measured: one day
Percentage of subjects not using rescue analgesic medication within 24 h
Measured: one day
Time of the first rescue analgesic drug
Measured: one day
Total number of compressions within 24 hours.
Measured: one day
Incidence and severity of adverse events within 24 h
Measured: one day
Sedation scale score
Measured: one day
Respiratory depression events (defined as respiratory rate ≤ 8 breaths/min and/or saturation < 90%)
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start25 Nov 2022
- Primary completion4 Jul 2023
- Study completion4 Jul 2023
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, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
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
- NCT06204120
- Sponsor's protocol ID
- LY03014/CT-CHN-203
- Status last verified
- Jan 2024
- First submitted
- 22 Apr 2023
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 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 Abdominal Surgery
- ClinicalTrials.gov ID
- NCT06204120
- Acronym / sponsor ID
- LY03014/CT-CHN-203
- Conditions
- Pain, Postoperative
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Luye Pharma Group Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Nov 2022 (actual)
- Primary completion
- 4 Jul 2023 (actual)
- Study completion
- 4 Jul 2023 (actual)
- First posted
- 12 Jan 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 abdominal surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- 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 group 4 | Experimental | Drug: LPM3480392 Injection |
Who may qualify
- Ages
- 18 to 65 years
- 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;
- Aged 18-65 years (including the boundary value), male or female;
- Body mass index (BMI) 18-29 kg/m2 (including the boundary value), male body weight ≥ 50 kg; female body weight ≥ 45 kg;
- Subjects scheduled for elective abdominal surgery under general anesthesia, 1h ≤ duration of estimated surgery Interval ≤ 4h;
- 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 less than 1 day before surgery 60 mmHg or greater;
- Peripheral saturation (SpO2) < 92% at screening or before administration;
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 |
|---|---|---|
| LPM3480392 InjectionPCA administration | Drug | LPM3480392 injection group 1, LPM3480392 injection group 2, LPM3480392 injection group 3, LPM3480392 injection group 4 |
| PlaceboPCA administration | Drug | Placebo |
| morphine hydrochloride injectionPCA administration | Drug | morphine hydrochloride injection |
Primary outcome
SPID24(the Sum of Pain Intensity Differences in Pain Score from baseline Over 24 Hours)
Time frame: one day
Pain intensity will be evaluated using an 11-point (0-10) Numeric Pain Rating Scale (NPRS), with higher numbers indicating a higher pain intensity, administered over 24 hours.
7 secondary outcomes
Cumulative dose of rescue analgesic drugs within 24 h
Time frame: one day
Percentage of subjects not using rescue analgesic medication within 24 h
Time frame: one day
Time of the first rescue analgesic drug
Time frame: one day
Total number of compressions within 24 hours.
Time frame: one day
Incidence and severity of adverse events within 24 h
Time frame: one day
Sedation scale score
Time frame: one day
Respiratory depression events (defined as respiratory rate ≤ 8 breaths/min and/or saturation < 90%)
Time frame: one day
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 12 Jan 2024.
- Individual participant dataSharing planned: No
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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.
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 LPM3480392 Injection and morphine hydrochloride 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: finished, as of the sponsor's last update on 12 Jan 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?
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?
SPID24(the Sum of Pain Intensity Differences in Pain Score from baseline Over 24 Hours) (time frame: one day). 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 12 Jan 2024.