Efficacy and Safety of Intravenous Meloxicam in Subjects With Moderate-to-severe Pain Following Abdominal Surgery

Last updated: March 25, 2025
Sponsor: Yangtze River Pharmaceutical Group Co., Ltd.
Overall Status: Completed

Phase

3

Condition

N/A

Treatment

Sodium Chloride Injection

Meloxicam Injection

Clinical Study ID

NCT06904248
YZJ-MLXK-YZ-2208
  • Ages 18-70
  • All Genders

Study 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)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female between 18 and 75 years of age, inclusive.

  2. Be scheduled to undergo abdominal surgery under general anesthesia with anticipatedmoderate to severe postoperative pain.

  3. Be American Society of Anesthesiology (ASA) physical class 1 or 2.

  4. Be able to understand the pain intensity evaluation methods.

  5. 18kg/m^2<body mass index ≤30 kg/m^2.

  6. Female Participants must not be pregnant or lactating. Participants(including theirpartners)must agree to use appropriate contraception from the time of signing theinformed consent form until 3 months after the last dose.No plans for sperm or eggdonation during the study period.

  7. Be able to understand the study purpose and procedures, agree to participate in thestudy program, Voluntarily provide written informed consent.

Exclusion

Exclusion Criteria:

  1. Have a known allergy to meloxicam or any excipient of meloxicam, aspirin, othernon-steroidal anti-inflammatory drugs (NSAIDs) or to any peri- or postoperativemedications used in this study.

  2. 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 forparticipation in this study.

  3. Have a history of migraine, anxiety,seizures, cognitive dysfunction, or otherpsychiatric or neurological disorders that the investigator believes may interferewith the study evaluation.

  4. Participants with the following cardiovascular diseases or history:

  5. Severe cardiovascular diseases, NYHA heart function class II or above,myocardial infarction, angina, or coronary artery bypass grafting (CABG) withinthe preceding 12 months, severe arrhythmias, or abnormal ECG during thescreening period judged by the investigator as unsuitable for participation inthis study.

  6. Resting systolic blood pressure ≥160mmHg in a sitting or lying position, and/ordiastolic blood pressure ≥100mmHg during the screening period, from the signingof the informed consent to before anesthesia induction.

  7. Clinically significant respiratory insufficiency, hypotension, bradycardiaoccurring intraoperatively or postoperatively before randomization, judged bythe investigator as unsuitable for participation in this study.

  8. Have another painful physical condition judged by the investigator that may confoundthe assessments of post operative pain.

  9. Have (within 12 months) gastrointestinal ulceration, erforation, gastrointestinalbleeding, or abdominal surgery before the screening period judged by theinvestigator as unsuitable for participation in this study.

  10. Have a known bleeding disorder or be taking agents affecting coagulation judged bythe investigator as unsuitable for participation in this study.

  11. Participants at high risk of bleeding, including those with congenital bleedingdisorders (e.g., hemophilia), thrombocytopenia (platelet count below 0.75× the lowerlimit of normal), or abnormal platelet function (e.g., idiopathic thrombocytopenicpurpura, disseminated intravascular coagulation, congenital platelet dysfunction).

  12. ALT or AST >2 ULN, TBIL >1.5 ULN, PT >ULN+3s, APTT ≥ULN+10s, Cr ≥1.5×ULN during thescreening period, or any laboratory abnormalities judged by the investigator atscreening and/or before surgery that may increase the risk of participation.

  13. Blood glucose ≥11.1mmol/L from the screening period to before anesthesia induction.

  14. Use of the following drugs (not exceeding 5 half-lives of the drug) beforerandomization, except for anesthetics and sedative/analgesic drugs usedpreoperatively for invasive examinations as allowed by the protocol: NSAIDs (including compound preparations containing NSAIDs), opioids, anesthetics,sedatives, hypnotics, anticonvulsants, antipsychotics, other central nervous systeminhibitors with analgesic effects, and glucocorticoids (excluding topical andinhaled medications).

  15. Use traditional Chinese medicines or proprietary Chinese medicines that couldinterfere with the evaluation of efficacy or safety judged by the investigator.

  16. Have been receiving or have received opioid therapy defined Long-term use (continuous use ≥3 days) of opioid analgesics within 14 days before the screeningperiod.

  17. Have a history of alcohol abuse (regularly drinks > 14 units of alcohol per day: 1unit = 360mL beer or 45mL of 40 % spirits or 150mL wine) within the past 2 years ora history of acute alcohol intoxication, alcohol dependence, drug abuse.

  18. Have received any drug/device clinical trials within 3 months before dosing withstudy medication.

  19. Have other conditions that make the subject unsuitable for participation in theclinical study in the opinion of the investigator.

Study Design

Total Participants: 224
Treatment Group(s): 2
Primary Treatment: Sodium Chloride Injection
Phase: 3
Study Start date:
January 29, 2024
Estimated Completion Date:
February 10, 2025

Connect with a study center

  • Cangzhou People's Hospital

    Cangzhou,
    China

    Site Not Available

  • The Third Xiangya Hospital Of Central South University

    Changsha,
    China

    Site Not Available

  • Heping Hospital Affiliated To Changzhi Medical College

    Changzhi,
    China

    Site Not Available

  • Sichuan Academy of Medical Sciengces & Sichuan Provincial People's Hospital

    Chengdu,
    China

    Site Not Available

  • The Second People's Hospital Of Chengdu

    Chengdu,
    China

    Site Not Available

  • The Third People's Hospital Of Chengdu

    Chengdu,
    China

    Site Not Available

  • The First People's Hospital Of Guangyuan

    Guangyuan,
    China

    Site Not Available

  • The First affiliated Hospital Of Jinan University

    Guangzhou,
    China

    Site Not Available

  • The Affiliated Hospital Of Guizhou Medical University

    Guizhou,
    China

    Site Not Available

  • Haikou People's Hospital

    Haikou,
    China

    Site Not Available

  • The Second Hospital Of Anhui Medical University

    Hefei,
    China

    Site Not Available

  • The First Affiliated Hospital Of University Of South ChinaThe First Affiliated Hospital Of University Of South China

    Hengyang,
    China

    Site Not Available

  • Meihekou Central Hospital

    Meihekou,
    China

    Site Not Available

  • Nanjing Women and Children's Healthcare Hospital

    Nanjing,
    China

    Site Not Available

  • The Second Nanning People's Hospital

    Nanning,
    China

    Site Not Available

  • Ningbo Medical Center Lihuili Hospital

    Ningbo,
    China

    Site Not Available

  • The Second Affiliated Hospital of Wenzhou Medical University

    Wenzhou,
    China

    Site Not Available

  • The First Affiliated Hospital Of Xi'an Medical University

    Xi'an,
    China

    Site Not Available

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