ClinicalTrials.gg
CompletedNCT06904248Updated Apr 1, 2025

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

A Phase 3 interventional study of Meloxicam Injection and Sodium Chloride Injection in Participants With Acute Moderate to Severe Pain Following Abdominal Surgery, sponsored by Yangtze River Pharmaceutical Group Co., Ltd.. Completed at 18 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-04-01.

Sponsored by Yangtze River Pharmaceutical Group Co., Ltd. · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Jan 2024, registered Mar 2025).
Phase
Phase 3
Study type
Interventional
Enrollment
224
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

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)

02

Conditions studied

  • Participants With Acute Moderate to Severe Pain Following Abdominal Surgery
03

In context

Lead sponsor

Yangtze River Pharmaceutical Group Co., Ltd. is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
224 participants (actual)

Study arms

  • Experimental
    Meloxicam Injection

    Drug: Meloxicam Injection

  • Placebo comparator
    Placebo

    Drug: Sodium Chloride Injection

Interventions

  • Intravenous meloxicam Injection, 30mg every 24 hours, for a total of 2 doses

  • DrugSodium Chloride Injection

    Intravenous Sodium Chloride Injection, 18mg every 24 hours, for a total of 2 doses

06

What researchers measure

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.

    Time frame: 24 Hours

Secondary outcomes

  1. Proportion of Participants Utilizing Rescue Analgesia

    Rescue analgesia (Morphine Hydrochloride Injection 2mg) was available to Participants with inadequately controlled pain upon request.

    Time frame: 48 Hours

  2. Number of Doses of Rescue Analgesia Utilized Subject

    Rescue analgesia (Morphine Hydrochloride Injection 2mg) was available to Participants with inadequately controlled pain upon request.

    Time frame: 48 Hours

  3. Number of Times of Rescue Analgesia Utilized Subject

    Rescue analgesia (Morphine Hydrochloride Injection 2mg) was available to Participants with inadequately controlled pain upon request.

    Time frame: 48 Hours

  4. Summed Pain Intensity Difference (SPID) at Other Intervals

    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.

    Time frame: 48 Hours

  5. TOTPAR (Total Pain Relief)

    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)

    Time frame: 48 Hours

  6. Time to First Dose of Rescue Analgesia

    Rescue analgesia (Morphine Hydrochloride Injection 2mg) was available to Participants with inadequately controlled pain upon request.

    Time frame: 48 Hours

  7. Investigator and subject satisfaction scores for analgesic treatment

    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.

    Time frame: 48 Hours

07

Study locations

18 sites
  • 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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06904248
Lead sponsor
Yangtze River Pharmaceutical Group Co., Ltd.
Responsible party
Sponsor
First posted
Apr 1, 2025
Start date
Jan 29, 2024
Primary completion
Nov 20, 2024
Completion
Feb 10, 2025
Last update
Apr 1, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Meloxicam

Start the discussion