Efficacy and Safety Study of Meloxicam Nanocrystal Injection for the Treatment of Moderate to Severe Pain
- Registration Number
- NCT06379165
- Lead Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of meloxicam nanocrystal injection in subjects with moderate to severe pain after abdominal surgery.
- Detailed Description
In this study, a randomized, double-blind, placebo-controlled multicenter study will be conducted to evaluate the efficacy and safety of meloxicam nanocrystal injection in subjects with moderate to severe pain after abdominal surgery.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 192
- 18 years ≤ age ≤ 65 years, regardless of gender.
- Elective abdominal surgery under general anesthesia.
- ASA score of grade 1-3.
- 18 kg/m^2 < BMI < 30 kg/m^2.
- NRS score of ≥ 4 within 3 hours after the end of surgery (last suture).
- Able to understand the study process and the use of pain scales, and able to communicate effectively with study personnel.
- Written informed consent signed by subject or legal representative.
- Abnormal liver function: ALT and/or AST > 2 × ULN, or TBIL ≥ 2 × ULN.
- Renal impairment (blood creatinine > 1.5 × ULN), or dialysis treatment within 28 days prior to the surgery.
- Subjects at high risk of bleeding, including subjects with congenital bleeding disorders (e.g., hemophilia), thrombocytopenic subjects (platelet count less than 50 × 10^9/L), subjects with abnormal platelet function (e.g., idiopathic thrombocytopenic purpura, disseminated intravascular coagulation, congenital abnormal platelet function), or subjects with any clinically significant active bleeding.
- Abnormal coagulation (PT>ULN+3s and/or APTT>ULN+10s).
- Subjects with a history of severe gastrointestinal disease (e.g. ulcers, bleeding and perforation, etc.) within 1 year prior to randomization that may be worsened by the administration of NSAIDs-like drugs.
- Myocardial infarction or coronary artery bypass grafting within 1 year prior to randomization.
- Abnormal clinically significant 12-lead ECG during the screening period and judged by the investigator to be inappropriate for participation in this trial.
- Combination of severe liver, kidney, cardiovascular, cerebrovascular, or metabolic system disease, which is judged by the investigator to be inappropriate for participation in this trial.
- Subjects with combined neurological or psychiatric disorders such as migraine and seizures, which have been judged by the investigator to affect the evaluation of the efficacy of the trial drug.
- Subjects with hypertension whose blood pressure is not satisfactorily controlled by antihypertensive medication (screening period sitting systolic blood pressure ≥ 160 mmHg, and/or screening period diastolic blood pressure ≥ 100 mmHg).
- Sitting systolic blood pressure ≤ 90 mmHg at screening.
- Subjects with diabetes mellitus whose blood glucose is not satisfactorily controlled (random blood glucose ≥ 11.1 mmol/L during the screening period).
- Subjects with advanced malignancy or malignancy with extensive metastases.
- Combined with other physical pain conditions that may confound postoperative pain evaluation.
- Subjects with known hypersensitivity to meloxicam, any of the excipients in the study drug, aspirin, other non-steroidal anti-inflammatory drugs (NSAIDs), any perioperative drug use, or other history of anaphylactic reactions.
- Subjects with alcohol or drug dependence within 3 months prior to screening and/or subjects whose alcohol, drug, or medication withdrawal may interfere with efficacy and safety evaluations during the study period.
- Subjects who have undergone abdominal surgery within 6 months prior to randomization.
- Subjects who have participated in other clinical trials and received the test drug/test device within 3 months prior to randomization.
- Subjects with contraindications to investigational drugs, standard anesthetic practices.
- Women who are pregnant or breastfeeding.
- Other reasons that the investigator deems inappropriate for participation in the trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Meloxicam Nanocrystal Injection Meloxicam Nanocrystal Injection The eligible subjects will receive Meloxicam Nanocrystal Injection, administered as 30 mg (1 mL) every 24 h for 2 doses. Placebo Placebo The eligible subjects will receive Placebo, administered as 1 mL Placebo every 24 h for 2 doses.
- Primary Outcome Measures
Name Time Method PID24 (Time Weighted Sum of Pain Intensity Difference Over 24 Hours Post-Dose) 24 hours after first dose The primary efficacy variable was the Pain Intensity (PI) measured by the Numerical Rating Scale (NRS); a scale from zero to 10 on which subjects circled a single number to indicate current pain level, with zero representing "No Pain" and 10 representing "Worst Possible Pain".
- Secondary Outcome Measures
Name Time Method Number of times of remedial analgesia administered 0-24h and 24-48h after the first dose 0-48 hours after the first dose The total amount of remedial analgesia used 24 h and 48 h after the first dose 0-48 hours after the first dose TOTPAR (time-weighted sum of pain relief scores): TOTPAR12, TOTPAR18, TOTPAR24, TOTPAR48. 0-48 hours after the first dose pain relief intensity was recorded using a Likert Scale (Range 0-4) where 0 equates to no pain relief (worse), and 4 equates to the completely pain relief intensity (better). pain relief intensity scores were to be recorded at the following time points: 0.25, 0.5, 1, 1.5, 2 ，3，4，6 ，8，10，12，14，16，18，24，30，36，42 and 48hours post Dose 1. pain relief intensity at each time point were calculated and a time weighted summed pain relief intensity (TOTPAR) was then calculated. Time weighted TOTPAR calculations were computed by multiplying a weight factor to each score prior to summation. The weight factor at each time point was the time elapsed since the previous observation. A bigger TOTPAR value was better.
Proportion of subjects requiring remedial analgesia 0-48 hours after the first dose The investigator's satisfaction score (0-4 point categorical scale score) for the subject's analgesic treatment 48 hours after the first dose The investigator's satisfaction score was recorded using a Likert Scale (Range 0-4), A bigger value was better.
SPID2、SPID6、SPID12、SPID18、SPID18-24、SPID24-48、SPID42-48、SPID48 0-48 hours after the first dose Pain intensity was recorded using a Numeric Pain Rating Scale (Range 0-10) where 0 equates to no pain (better), and 10 equates to the worst pain imaginable (worse). Pain intensity scores were to be recorded at the following time points: 0.25, 0.5, 1, 1.5, 2 ，3，4，6 ，8，10，12，14，16，18，24，30，36，42 and 48hours post Dose 1. Pain intensity differences from baseline at each time point were calculated and a time weighted summed pain intensity difference (SPID) was then calculated. Time weighted SPID calculations were computed by multiplying a weight factor to each score prior to summation. The weight factor at each time point was the time elapsed since the previous observation. A smaller SPID value (i.e. more negative) was better.
The subject's analgesic treatment satisfaction score (0-4 point categorical scale score) 48 hours after the first dose The subject's analgesic treatment satisfaction score was recorded using a Likert Scale (Range 0-4), A bigger value was better.
Time to the first dose of the remedial analgesia 0-48 hours after the first dose
Trial Locations
- Locations (1)
Union Hospital of Tongji Medical College of Huazhong University of Science and Technology
🇨🇳Wuhan, China