- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06467409
Phase II Clinical Trial to Evaluate the Efficacy and Safety of LPM3480392 Injection for Moderate to Severe Pain After Orthopedic Surgery
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: xiangdong chen
- Phone Number: 15071096621
- Email: xiangdongchen2013@163.com
Study Locations
-
-
-
Wuhan, China
- Recruiting
- Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
-
Contact:
- xiangdong chen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- 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 :
a) 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
patient-controlled analgesia(PCA) administration
|
Active Comparator: morphine hydrochloride injection
|
patient-controlled analgesia(PCA) administration
|
Experimental: LPM3480392 injection group 1
|
patient-controlled analgesia(PCA) administration
|
Experimental: LPM3480392 injection group 2
|
patient-controlled analgesia(PCA) administration
|
Experimental: LPM3480392 injection group 3
|
patient-controlled analgesia(PCA) administration
|
Experimental: LPM3480392 injection group4
|
patient-controlled analgesia(PCA) administration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SPID48
Time Frame: 48 hours
|
the Sum of Pain Intensity Differences in Pain Score from baseline Over 48 Hours
|
48 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cumulative dose of rescue analgesic drugs
Time Frame: 48 hours
|
48 hours
|
Incidence of adverse events
Time Frame: 48 hours
|
48 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LY03014/CT-CHN-204
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain, Postoperative
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
Ankara City Hospital BilkentRecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | SternotomyTurkey
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Thoracotomy | Postoperative Pain, Acute | Postoperative Pain, ChronicTurkey
-
Aydin Adnan Menderes UniversityCompleted
-
Aydin Adnan Menderes UniversityCompletedAcute Postoperative Pain | Chronic Postoperative PainTurkey
-
VA Office of Research and DevelopmentRecruitingTotal Knee Arthroplasty (Postoperative Pain) | Total Hip Arthroplasty (Postoperative Pain)United States
-
VA Office of Research and DevelopmentCompletedTotal Knee Arthroplasty (Postoperative Pain) | Total Hip Arthroplasty(Postoperative Pain)United States
-
Hospital of South West JutlandNovo Nordisk A/SRecruitingPhysical Activity | Postoperative Pain, Acute | Postoperative Pain, Chronic | Bariatric Surgery | MobilizationDenmark
-
University of ManitobaUnknown
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States