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 range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.
. 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.
. 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.