Efficacy and Safety of Intravenous Meloxicam in Subjects With Moderate-to-severe Pain Following Abdominal Surgery
Evaluation of the Efficacy and Safety of Meloxicam Injection for Postoperative Analgesia in Abdominal Surgery Patients: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3 Clinical Trial
1 other identifier
interventional
224
1 country
18
Brief 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2024
Shorter than P25 for phase_3
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 10, 2025
CompletedFirst Submitted
Initial submission to the registry
March 25, 2025
CompletedFirst Posted
Study publicly available on registry
April 1, 2025
CompletedApril 1, 2025
March 1, 2025
10 months
March 25, 2025
March 25, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Summed Pain Intensity Difference Over the First 24 Hours (SPID24)
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: 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 14 hours, 16 hours, 18 hours and 24 hours post Dose1. 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.
24 Hours
Secondary Outcomes (7)
Proportion of Participants Utilizing Rescue Analgesia
48 Hours
Number of Doses of Rescue Analgesia Utilized Subject
48 Hours
Number of Times of Rescue Analgesia Utilized Subject
48 Hours
Summed Pain Intensity Difference (SPID) at Other Intervals
48 Hours
TOTPAR (Total Pain Relief)
48 Hours
- +2 more secondary outcomes
Study Arms (2)
Meloxicam Injection
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Intravenous meloxicam Injection, 30mg every 24 hours, for a total of 2 doses
Intravenous Sodium Chloride Injection, 18mg every 24 hours, for a total of 2 doses
Eligibility Criteria
You may qualify if:
- 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.
- kg/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.
You may not qualify if:
- 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.
- Have (within 12 months) gastrointestinal ulceration, erforation, gastrointestinal bleeding, or abdominal surgery before the screening period judged by the investigator as unsuitable for participation in this study.
- Have a known bleeding disorder or be taking agents affecting coagulation judged by the investigator as unsuitable for participation in this study.
- Participants at high risk of bleeding, including those with congenital bleeding disorders (e.g., hemophilia), thrombocytopenia (platelet count below 0.75× the lower limit of normal), or abnormal platelet function (e.g., idiopathic thrombocytopenic purpura, disseminated intravascular coagulation, congenital platelet dysfunction).
- ALT or AST \>2 ULN, TBIL \>1.5 ULN, PT \>ULN+3s, APTT ≥ULN+10s, Cr ≥1.5×ULN during the screening period, or any laboratory abnormalities judged by the investigator at screening and/or before surgery that may increase the risk of participation.
- Blood glucose ≥11.1mmol/L from the screening period to before anesthesia induction.
- Use of the following drugs (not exceeding 5 half-lives of the drug) before randomization, except for anesthetics and sedative/analgesic drugs used preoperatively for invasive examinations as allowed by the protocol: NSAIDs (including compound preparations containing NSAIDs), opioids, anesthetics, sedatives, hypnotics, anticonvulsants, antipsychotics, other central nervous system inhibitors with analgesic effects, and glucocorticoids (excluding topical and inhaled medications).
- Use traditional Chinese medicines or proprietary Chinese medicines that could interfere with the evaluation of efficacy or safety judged by the investigator.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Cangzhou People's Hospital
Cangzhou, China
The Third Xiangya Hospital Of Central South University
Changsha, China
Heping Hospital Affiliated To Changzhi Medical College
Changzhi, China
Sichuan Academy of Medical Sciengces & Sichuan Provincial People's Hospital
Chengdu, China
The Second People's Hospital Of Chengdu
Chengdu, China
The Third People's Hospital Of Chengdu
Chengdu, China
The First People's Hospital Of Guangyuan
Guangyuan, China
The First affiliated Hospital Of Jinan University
Guangzhou, China
The Affiliated Hospital Of Guizhou Medical University
Guizhou, China
Haikou People's Hospital
Haikou, China
The Second Hospital Of Anhui Medical University
Hefei, China
The First Affiliated Hospital Of University Of South ChinaThe First Affiliated Hospital Of University Of South China
Hengyang, China
Meihekou Central Hospital
Meihekou, China
Nanjing Women and Children's Healthcare Hospital
Nanjing, China
The Second Nanning People's Hospital
Nanning, China
Ningbo Medical Center Lihuili Hospital
Ningbo, China
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
The First Affiliated Hospital Of Xi'an Medical University
Xi'an, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2025
First Posted
April 1, 2025
Study Start
January 29, 2024
Primary Completion
November 20, 2024
Study Completion
February 10, 2025
Last Updated
April 1, 2025
Record last verified: 2025-03