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Participants With Acute Moderate to Severe Pain Following Abdominal SurgeryPhase 3NCT06904248

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

A Phase 3 study testing Meloxicam Injection and Sodium Chloride Injection in people with Participants With Acute Moderate to Severe Pain Following Abdominal Surgery, run by Yangtze River Pharmaceutical Group Co., Ltd. at 18 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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) Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Meloxicam Injection and Sodium Chloride Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
224 participants
Where
18 sitesChina
Study dates
29 Jan 2024to 10 Feb 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.
Show all 19Show fewer
  • 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.
  • 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.
  • 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.
  • Have received any drug/device clinical trials within 3 months before dosing with study medication.
  • Have other conditions that make the subject unsuitable for participation in the clinical study in the opinion of the investigator.

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

China18 sites

  • Cangzhou People's Hospital

    Cangzhou

  • The Third Xiangya Hospital Of Central South University

    Changsha

  • Heping Hospital Affiliated To Changzhi Medical College

    Changzhi

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

    Chengdu

  • The Second People's Hospital Of Chengdu

    Chengdu

  • The Third People's Hospital Of Chengdu

    Chengdu

  • The First People's Hospital Of Guangyuan

    Guangyuan

  • The First affiliated Hospital Of Jinan University

    Guangzhou

  • The Affiliated Hospital Of Guizhou Medical University

    Guizhou

  • Haikou People's Hospital

    Haikou

  • The Second Hospital Of Anhui Medical University

    Hefei

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

    Hengyang

  • Meihekou Central Hospital

    Meihekou

  • Nanjing Women and Children's Healthcare Hospital

    Nanjing

  • The Second Nanning People's Hospital

    Nanning

  • Ningbo Medical Center Lihuili Hospital

    Ningbo

  • The Second Affiliated Hospital of Wenzhou Medical University

    Wenzhou

  • The First Affiliated Hospital Of Xi'an Medical University

    Xi'an

Other trials in China

About this study

Official title: 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)

Being tested
Meloxicam Injection, Sodium Chloride Injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Meloxicam InjectionDrug

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

  • Sodium Chloride InjectionDrug

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

Study groups in NCT06904248
Study groupRoleWhat they receive
Meloxicam InjectionExperimentalNot described
Receives: Drug: Meloxicam Injection
PlaceboPlacebo comparatorNot described
Receives: Drug: Sodium Chloride Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 24 Hours

Secondary outcomes (7)

  1. Proportion of Participants Utilizing Rescue Analgesia

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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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)

    Measured: 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.

    Measured: 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.

    Measured: 48 Hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2025
  2. Study start29 Jan 2024
  3. Primary completion20 Nov 2024
  4. Study completion10 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
224 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06904248
Sponsor's protocol ID
YZJ-MLXK-YZ-2208
Status last verified
Mar 2025
First submitted
25 Mar 2025
Last updated
1 Apr 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Meloxicam Injection and Sodium Chloride Injection in people with Participants With Acute Moderate to Severe Pain Following Abdominal Surgery, run by Yangtze River Pharmaceutical Group Co., Ltd. at 18 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Summed Pain Intensity Difference Over the First 24 Hours (SPID24) (time frame: 24 Hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06904248.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.

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