Efficacy and Safety of Intravenous Meloxicam in Subjects With Moderate-to-severe Pain Following A… (NCT06904248) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety of Intravenous Meloxicam in Subjects With Moderate-to-severe Pain Following Abdominal Surgery
China224 participantsStarted 2024-01-29
Plain-language summary
This study aims to evaluate the analgesic efficacy and safety of meloxicam injection in subjects with moderate-to-severe pain following abdominal surgery. The primary efficacy endpoint is the summed pain intensity difference over 24 hours ( SPID24)
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Male or female between 18 and 75 years of age, inclusive.
✓. Be scheduled to undergo abdominal surgery under general anesthesia with anticipated moderate to severe postoperative pain.
✓. Be American Society of Anesthesiology (ASA) physical class 1 or 2.
✓. Be able to understand the pain intensity evaluation methods.
✓. 18kg/m\^2\<body mass index ≤30 kg/m\^2.
✓. Female Participants must not be pregnant or lactating. Participants(including their partners)must agree to use appropriate contraception from the time of signing the informed consent form until 3 months after the last dose.No plans for sperm or egg donation during the study period.
✓. Be able to understand the study purpose and procedures, agree to participate in the study program, Voluntarily provide written informed consent.
Exclusion criteria
✕. Have a known allergy to meloxicam or any excipient of meloxicam, aspirin, other non-steroidal anti-inflammatory drugs (NSAIDs) or to any peri- or postoperative medications used in this study.
✕. Have a history or clinical manifestations of significant cerebrovascular, respiratory, renal, hepatic, endocrine, neurological, psychiatric systemic diseases, or advanced malignant tumors, and judged by the investigator as unsuitable for participation in this study.
✕. Have a history of migraine, anxiety,seizures, cognitive dysfunction, or other psychiatric or neurological disorders that the investigator believes may interfere with the study evaluation.
What they're measuring
1
Summed Pain Intensity Difference Over the First 24 Hours (SPID24)
Timeframe: 24 Hours
Trial details
NCT IDNCT06904248
SponsorYangtze River Pharmaceutical Group Co., Ltd.
✕. Participants with the following cardiovascular diseases or history:
✕. Severe cardiovascular diseases, NYHA heart function class II or above, myocardial infarction, angina, or coronary artery bypass grafting (CABG) within the preceding 12 months, severe arrhythmias, or abnormal ECG during the screening period judged by the investigator as unsuitable for participation in this study.
✕. Resting systolic blood pressure ≥160mmHg in a sitting or lying position, and/or diastolic blood pressure ≥100mmHg during the screening period, from the signing of the informed consent to before anesthesia induction.
✕. Clinically significant respiratory insufficiency, hypotension, bradycardia occurring intraoperatively or postoperatively before randomization, judged by the investigator as unsuitable for participation in this study.
✕. Have another painful physical condition judged by the investigator that may confound the assessments of post operative pain.