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

NCT06379165 | Completed Phase 3

• 1 other identifier: SYH9015-002
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain

Outcome Measures

Primary Outcomes (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".

  24 hours after first dose

Secondary Outcomes (8)

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

  0-48 hours after the first dose

• SPID2、SPID6、SPID12、SPID18、SPID18-24、SPID24-48、SPID42-48、SPID48

  0-48 hours after the first dose

• Time to the first dose of the remedial analgesia

  0-48 hours after the first dose

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

  0-48 hours after the first dose

• Proportion of subjects requiring remedial analgesia

  0-48 hours after the first dose

Study Arms (2)

Meloxicam Nanocrystal Injection

EXPERIMENTAL

The eligible subjects will receive Meloxicam Nanocrystal Injection, administered as 30 mg (1 mL) every 24 h for 2 doses.

Drug: Meloxicam Nanocrystal Injection

Placebo

PLACEBO COMPARATOR

The eligible subjects will receive Placebo, administered as 1 mL Placebo every 24 h for 2 doses.

Drug: Placebo

Interventions

Meloxicam Nanocrystal Injection DRUG

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

Meloxicam Nanocrystal Injection

Placebo DRUG

1 mL Placebo, once daily, by intravenous infusion

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years ≤ age ≤ 65 years, regardless of gender.
• Elective abdominal surgery under general anesthesia.
• ASA score of grade 1-3.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

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

Wuhan, China

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chen xiangdong

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2023
• First Posted: April 23, 2024
• Study Start: May 17, 2023
• Primary Completion: July 11, 2023
• Study Completion: July 13, 2023
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)