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PainPhase 3NCT06379165

Efficacy and Safety Study of Meloxicam Nanocrystal Injection for the Treatment of Moderate to Severe Pain

A Phase 3 study testing Meloxicam Nanocrystal Injection in people with Pain, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site 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

The purpose of this study is to evaluate the efficacy and safety of meloxicam nanocrystal injection in subjects with moderate to severe pain after abdominal surgery. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Pain
What is being tested?
Meloxicam Nanocrystal Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
192 participants
Where
1 siteChina
Study dates
17 May 2023to 13 Jul 2023
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years ≤ age ≤ 65 years, regardless of gender.
  • Elective abdominal surgery under general anesthesia.
  • ASA score of grade 1-3.
  • 18 kg/m^2 < BMI < 30 kg/m^2.
  • NRS score of ≥ 4 within 3 hours after the end of surgery (last suture).
  • Able to understand the study process and the use of pain scales, and able to communicate effectively with study personnel.
  • Written informed consent signed by subject or legal representative.

Who cannot join

  • Abnormal liver function: ALT and/or AST > 2 × ULN, or TBIL ≥ 2 × ULN.
  • Renal impairment (blood creatinine > 1.5 × ULN), or dialysis treatment within 28 days prior to the surgery.
  • Subjects at high risk of bleeding, including subjects with congenital bleeding disorders (e.g., hemophilia), thrombocytopenic subjects (platelet count less than 50 × 10^9/L), subjects with abnormal platelet function (e.g., idiopathic thrombocytopenic purpura, disseminated intravascular coagulation, congenital abnormal platelet function), or subjects with any clinically significant active bleeding.
  • Abnormal coagulation (PT>ULN+3s and/or APTT>ULN+10s).
  • Subjects with a history of severe gastrointestinal disease (e.g. ulcers, bleeding and perforation, etc.) within 1 year prior to randomization that may be worsened by the administration of NSAIDs-like drugs.
  • Myocardial infarction or coronary artery bypass grafting within 1 year prior to randomization.
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  • Abnormal clinically significant 12-lead ECG during the screening period and judged by the investigator to be inappropriate for participation in this trial.
  • Combination of severe liver, kidney, cardiovascular, cerebrovascular, or metabolic system disease, which is judged by the investigator to be inappropriate for participation in this trial.
  • Subjects with combined neurological or psychiatric disorders such as migraine and seizures, which have been judged by the investigator to affect the evaluation of the efficacy of the trial drug.
  • Subjects with hypertension whose blood pressure is not satisfactorily controlled by antihypertensive medication (screening period sitting systolic blood pressure ≥ 160 mmHg, and/or screening period diastolic blood pressure ≥ 100 mmHg).
  • Sitting systolic blood pressure ≤ 90 mmHg at screening.
  • Subjects with diabetes mellitus whose blood glucose is not satisfactorily controlled (random blood glucose ≥ 11.1 mmol/L during the screening period).
  • Subjects with advanced malignancy or malignancy with extensive metastases.
  • Combined with other physical pain conditions that may confound postoperative pain evaluation.
  • Subjects with known hypersensitivity to meloxicam, any of the excipients in the study drug, aspirin, other non-steroidal anti-inflammatory drugs (NSAIDs), any perioperative drug use, or other history of anaphylactic reactions.
  • Subjects with alcohol or drug dependence within 3 months prior to screening and/or subjects whose alcohol, drug, or medication withdrawal may interfere with efficacy and safety evaluations during the study period.
  • Subjects who have undergone abdominal surgery within 6 months prior to randomization.
  • Subjects who have participated in other clinical trials and received the test drug/test device within 3 months prior to randomization.
  • Subjects with contraindications to investigational drugs, standard anesthetic practices.
  • Women who are pregnant or breastfeeding.
  • Other reasons that the investigator deems inappropriate for participation in the trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Union Hospital of Tongji Medical College of Huazhong University of Science and Technology

    Wuhan

Other trials in China

About this study

Official title: Efficacy and Safety Study of Meloxicam Nanocrystal Injection for the Treatment of Moderate to Severe Pain After Abdominal Surgery - a Multicenter, Randomized, Double-blind, Placebo-parallel Controlled, Phase III Clinical Trial

The purpose of this study is to evaluate the efficacy and safety of meloxicam nanocrystal injection in subjects with moderate to severe pain after abdominal surgery.

Read the detailed description

In this study, a randomized, double-blind, placebo-controlled multicenter study will be conducted to evaluate the efficacy and safety of meloxicam nanocrystal injection in subjects with moderate to severe pain after abdominal surgery.

Conditions
Pain
Being tested
Meloxicam Nanocrystal Injection, Placebo
Medical subject headings
Pain

What participants receive

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

  • Meloxicam Nanocrystal InjectionDrug

    30 mg (1 mL), once daily, by intravenous infusion

  • PlaceboDrug

    1 mL Placebo, once daily, by intravenous infusion

Study groups in NCT06379165
Study groupRoleWhat they receive
Meloxicam Nanocrystal InjectionExperimentalThe eligible subjects will receive Meloxicam Nanocrystal Injection, administered as 30 mg (1 mL) every 24 h for 2 doses.
Receives: Drug: Meloxicam Nanocrystal Injection
PlaceboPlacebo comparatorThe eligible subjects will receive Placebo, administered as 1 mL Placebo every 24 h for 2 doses.
Receives: Drug: Placebo

What is being measured

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

  1. PID24 (Time Weighted Sum of Pain Intensity Difference Over 24 Hours Post-Dose)

    The primary efficacy variable was the Pain Intensity (PI) measured by the Numerical Rating Scale (NRS); a scale from zero to 10 on which subjects circled a single number to indicate current pain level, with zero representing "No Pain" and 10 representing "Worst Possible Pain".

    Measured: 24 hours after first dose

Secondary outcomes (8)

  1. TOTPAR (time-weighted sum of pain relief scores): TOTPAR12, TOTPAR18, TOTPAR24, TOTPAR48.

    pain relief intensity was recorded using a Likert Scale (Range 0-4) where 0 equates to no pain relief (worse), and 4 equates to the completely pain relief intensity (better). pain relief intensity scores were to be recorded at the following time points: 0.25, 0.5, 1, 1.5, 2 ，3，4，6 ，8，10，12，14，16，18，24，30，36，42 and 48hours post Dose 1. pain relief intensity at each time point were calculated and a time weighted summed pain relief intensity (TOTPAR) was then calculated. Time weighted TOTPAR 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 bigger TOTPAR value was better.

    Measured: 0-48 hours after the first dose

  2. SPID2、SPID6、SPID12、SPID18、SPID18-24、SPID24-48、SPID42-48、SPID48

    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: 0.25, 0.5, 1, 1.5, 2 ，3，4，6 ，8，10，12，14，16，18，24，30，36，42 and 48hours 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: 0-48 hours after the first dose

  3. Time to the first dose of the remedial analgesia

    Measured: 0-48 hours after the first dose

  4. Number of times of remedial analgesia administered 0-24h and 24-48h after the first dose

    Measured: 0-48 hours after the first dose

  5. Proportion of subjects requiring remedial analgesia

    Measured: 0-48 hours after the first dose

  6. The total amount of remedial analgesia used 24 h and 48 h after the first dose

    Measured: 0-48 hours after the first dose

  7. The subject's analgesic treatment satisfaction score (0-4 point categorical scale score)

    The subject's analgesic treatment satisfaction score was recorded using a Likert Scale (Range 0-4), A bigger value was better.

    Measured: 48 hours after the first dose

  8. The investigator's satisfaction score (0-4 point categorical scale score) for the subject's analgesic treatment

    The investigator's satisfaction score was recorded using a Likert Scale (Range 0-4), A bigger value was better.

    Measured: 48 hours after the first dose

Timeline

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

  1. First posted23 Apr 2024
  2. Study start17 May 2023
  3. Primary completion11 Jul 2023
  4. Study completion13 Jul 2023

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
192 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06379165
Sponsor's protocol ID
SYH9015-002
Status last verified
Apr 2024
First submitted
28 Jan 2023
Last updated
23 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Meloxicam Nanocrystal Injection in people with Pain, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site 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 21 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 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

PID24 (Time Weighted Sum of Pain Intensity Difference Over 24 Hours Post-Dose) (time frame: 24 hours after first dose). 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 NCT06379165.

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 23 Apr 2024.

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