Clinical trial NCT06379165: Efficacy and Safety Study of Meloxicam Nanocrystal Injection for the Treatment of Moderate to Severe Pain
Official title: Efficacy and Safety Study of Meloxicam Nanocrystal Injection for the Treatment of Moderate to Severe Pain After Abdominal Surgery - a Multicenter, Randomized, Double-blind, Placebo-parallel Controlled, Phase III Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Lead sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-04-23
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. 18 years ≤ age ≤ 65 years, regardless of gender.
2. Elective abdominal surgery under general anesthesia.
3. ASA score of grade 1-3.
4. 18 kg/m\^2 \< BMI \< 30 kg/m\^2.
5. NRS score of ≥ 4 within 3 hours after the end of surgery (last suture).
6. Able to understand the study process and the use of pain scales, and able to communicate effectively with study personnel.
7. Written informed consent signed by subject or legal representative.

Exclusion Criteria:

1. Abnormal liver function: ALT and/or AST \> 2 × ULN, or TBIL ≥ 2 × ULN.
2. Renal impairment (blood creatinine \> 1.5 × ULN), or dialysis treatment within 28 days prior to the surgery.
3. 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.
4. Abnormal coagulation (PT\>ULN+3s and/or APTT\>ULN+10s).
5. 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.
6. Myocardial infarction or coronary artery bypass grafting within 1 year prior to randomization.
7. Abnormal clinically significant 12-lead ECG during the screening period and judged by the investigator to be inappropriate for participation in this trial.
8. 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.
9. 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.
10. 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).
11. Sitting systolic blood pressure ≤ 90 mmHg at screening.
12. Subjects with diabetes mellitus whose blood glucose is not satisfactorily controlled (random blood glucose ≥ 11.1 mmol/L during the screening period).
13. Subjects with advanced malignancy or malignancy with extensive metastases.
14. Combined with other physical pain conditions that may confound postoperative pain evaluation.
15. 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.
16. 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.
17. Subjects who have undergone abdominal surgery within 6 months prior to randomization.
18. Subjects who have participated in other clinical trials and received the test drug/test device within 3 months prior to randomization.
19. Subjects with contraindications to investigational drugs, standard anesthetic practices.
20. Women who are pregnant or breastfeeding.
21. Other reasons that the investigator deems inappropriate for participation in the trial.

Primary outcomes:
measure: PID24 (Time Weighted Sum of Pain Intensity Difference Over 24 Hours Post-Dose)
timeFrame: 24 hours after first dose
Secondary outcomes:
measure: TOTPAR (time-weighted sum of pain relief scores): TOTPAR12, TOTPAR18, TOTPAR24, TOTPAR48.
timeFrame: 0-48 hours after the first dose
measure: SPID2、SPID6、SPID12、SPID18、SPID18-24、SPID24-48、SPID42-48、SPID48
timeFrame: 0-48 hours after the first dose
measure: Time to the first dose of the remedial analgesia
timeFrame: 0-48 hours after the first dose
measure: Number of times of remedial analgesia administered 0-24h and 24-48h after the first dose
timeFrame: 0-48 hours after the first dose
measure: Proportion of subjects requiring remedial analgesia
timeFrame: 0-48 hours after the first dose
measure: The total amount of remedial analgesia used 24 h and 48 h after the first dose
timeFrame: 0-48 hours after the first dose
measure: The subject's analgesic treatment satisfaction score (0-4 point categorical scale score)
timeFrame: 48 hours after the first dose
measure: The investigator's satisfaction score (0-4 point categorical scale score) for the subject's analgesic treatment
timeFrame: 48 hours after the first dose
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union Hospital of Tongji Medical College of Huazhong University of Science and Technology
Study officials:
affiliation: Union Hospital of Tongji Medical College of Huazhong University of Science and Technology
name: Chen xiangdong
role: PRINCIPAL_INVESTIGATOR
References: