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

March 25, 2025 updated by: Yangtze River Pharmaceutical Group Co., Ltd.

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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

224

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Cangzhou, China
        • Cangzhou People's Hospital
      • Changsha, China
        • The Third Xiangya Hospital of Central South University
      • Changzhi, China
        • Heping Hospital Affiliated to Changzhi Medical College
      • Chengdu, China
        • The Second People's Hospital of Chengdu
      • Chengdu, China
        • The Third People's Hospital of Chengdu
      • Chengdu, China
        • Sichuan Academy of Medical Sciengces & Sichuan Provincial People's Hospital
      • Guangyuan, China
        • The First People's Hospital of Guangyuan
      • Guangzhou, China
        • The First Affiliated Hospital of Jinan University
      • Guizhou, China
        • The Affiliated Hospital of Guizhou Medical University
      • Haikou, China
        • Haikou People's Hospital
      • Hefei, China
        • The Second Hospital of Anhui Medical University
      • Hengyang, China
        • The First Affiliated Hospital Of University Of South ChinaThe First Affiliated Hospital Of University Of South China
      • Meihekou, China
        • Meihekou Central Hospital
      • Nanjing, China
        • Nanjing Women and Children's Healthcare Hospital
      • Nanning, China
        • The Second Nanning People's Hospital
      • Ningbo, China
        • Ningbo Medical Center Lihuili Hospital
      • Wenzhou, China
        • The Second Affiliated Hospital of Wenzhou Medical University
      • Xi'an, China
        • The First Affiliated Hospital of Xi'an Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Exclusion Criteria:

  1. 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.
  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 for participation in this study.
  3. 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.

  4. Participants with the following cardiovascular diseases or history:

    1. 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.
    2. 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.
    3. Clinically significant respiratory insufficiency, hypotension, bradycardia occurring intraoperatively or postoperatively before randomization, judged by the investigator as unsuitable for participation in this study.
  5. Have another painful physical condition judged by the investigator that may confound the assessments of post operative pain.
  6. 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.
  7. Have a known bleeding disorder or be taking agents affecting coagulation judged by the investigator as unsuitable for participation in this study.
  8. 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).
  9. 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.
  10. Blood glucose ≥11.1mmol/L from the screening period to before anesthesia induction.
  11. 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).
  12. Use traditional Chinese medicines or proprietary Chinese medicines that could interfere with the evaluation of efficacy or safety judged by the investigator.
  13. Have been receiving or have received opioid therapy defined Long-term use (continuous use ≥3 days) of opioid analgesics within 14 days before the screening period.
  14. Have a history of alcohol abuse (regularly drinks > 14 units of alcohol per day: 1 unit = 360mL beer or 45mL of 40 % spirits or 150mL wine) within the past 2 years or a history of acute alcohol intoxication, alcohol dependence, drug abuse.
  15. Have received any drug/device clinical trials within 3 months before dosing with study medication.
  16. Have other conditions that make the subject unsuitable for participation in the clinical study in the opinion of the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Sodium Chloride Injection
Intravenous Sodium Chloride Injection, 18mg every 24 hours, for a total of 2 doses
Experimental: Meloxicam Injection
Drug: Meloxicam Injection
Intravenous meloxicam Injection, 30mg every 24 hours, for a total of 2 doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Summed Pain Intensity Difference Over the First 24 Hours (SPID24)
Time Frame: 24 Hours
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants Utilizing Rescue Analgesia
Time Frame: 48 Hours
Rescue analgesia (Morphine Hydrochloride Injection 2mg) was available to Participants with inadequately controlled pain upon request.
48 Hours
Number of Doses of Rescue Analgesia Utilized Subject
Time Frame: 48 Hours
Rescue analgesia (Morphine Hydrochloride Injection 2mg) was available to Participants with inadequately controlled pain upon request.
48 Hours
Number of Times of Rescue Analgesia Utilized Subject
Time Frame: 48 Hours
Rescue analgesia (Morphine Hydrochloride Injection 2mg) was available to Participants with inadequately controlled pain upon request.
48 Hours
Summed Pain Intensity Difference (SPID) at Other Intervals
Time Frame: 48 Hours
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 hours post Dose1. Thereafter pain assessments were to be recorded every 6 hours until 48 hours post Dose 1. 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.
48 Hours
TOTPAR (Total Pain Relief)
Time Frame: 48 Hours
Pain relief will be evaluated considering the Sum of Total Pain Relief (TOTPAR) over 0-12 hours，0-18 hours，0-24 hours，0-48 hours post-dose. Pain relief will be evaluate using a Categorical Pain Relief Rating Scale (0 = No relief, 1 = Mild relief, 2 = Moderate relief, 3 = Marked relief, 4 = complete relief)
48 Hours
Time to First Dose of Rescue Analgesia
Time Frame: 48 Hours
Rescue analgesia (Morphine Hydrochloride Injection 2mg) was available to Participants with inadequately controlled pain upon request.
48 Hours
Investigator and subject satisfaction scores for analgesic treatment
Time Frame: 48 Hours
Satisfaction scores will be evaluate using a 5 point scale (0-4) with categories of 0-poor, 1-fair, 2-good, 3-very good, or 4-excellent.
48 Hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yangtze River Pharmaceutical Group Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 29, 2024

Primary Completion (Actual)

November 20, 2024

Study Completion (Actual)

February 10, 2025

Study Registration Dates

First Submitted

March 25, 2025

First Submitted That Met QC Criteria

March 25, 2025

First Posted (Actual)

April 1, 2025

Study Record Updates

Last Update Posted (Actual)

April 1, 2025

Last Update Submitted That Met QC Criteria

March 25, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YZJ-MLXK-YZ-2208

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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