Efficacy, Safety and Tolerability Study of Meloxicam Injection in Subjects After Abdominal Surgery
- Conditions
- Pain, Post-operative
- Interventions
- Registration Number
- NCT05950152
- Lead Sponsor
- Beijing Tide Pharmaceutical Co., Ltd
- Brief Summary
The purpose of this study is to determine the analgesic efficacy and safety of Meloxicam Injection in subjects undergoing abdominal surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 108
Voluntarily provide written informed consent. Be scheduled to undergo elective abdominoplasty surgery without collateral procedures.
Be American Society of Anesthesiology (ASA) physical class 1 or 2. Male or female between 18 and 70 years of age, inclusive. Have a body mass index 18~30 kg/m2. Be able to understand the study procedures, comply with all study procedures, and agree to participate in the study program.
Have a history of abdominoplasty surgery within the preceding 12 months. Have active or recent (within 6 months) gastrointestinal ulceration or bleeding.
Have a history of myocardial infarction or coronary artery bypass graft surgery within the preceding 12 months.
Have a history or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, or other condition that would preclude participation in the study.
Have a history of migraine or frequent headaches, seizures, or are currently taking anticonvulsants.
Have another painful physical condition that may confound the assessments of post operative pain.
Have a history of advanced malignant tumor. Have a history of alcohol abuse (regularly drinks > 4 units of alcohol per day; 8 oz. beer, 3 oz. wine, 1 oz. spirits) within the past 5 years or a history of prescription/illicit drug abuse.
Have positive results on the urine drug screen or alcohol breath test indicative of illicit drug or alcohol abuse.
Have evidence of a clinically significant 12 lead ECG abnormality. Have a clinically significant abnormal clinical laboratory test value. Have history of or positive test results for HIV, treponema pallidum,or hepatitis B or C.
Have a known allergy to meloxicam or any excipient of N1539, D5W, aspirin, other non-steroidal anti-inflammatory drugs (NSAIDs) or to any peri- or postoperative medications used in this study.
Have been receiving or have received chronic opioid therapy defined as greater than 15 morphine equivalents units per day for greater than 3 out of 7 days per week over a one-month period within 12 months of surgery.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description meloxicam injection 60 mg Meloxicam Injection 60mg meloxicam injection 60mg every 24 hours for up to 2 doses IV Placebo Nacl 0.9% IV Placebo every 24 hours for up to 2 doses meloxicam injection 30 mg Meloxicam Injection 30mg meloxicam injection 30mg every 24 hours for up to 2 doses.
- Primary Outcome Measures
Name Time Method Summed Pain Intensity Difference Over the First 24 Hours (SPID24) 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: 0.25, 0.5, 0.75, 1, and 2 hours post Dose 1. Thereafter pain assessments were to be recorded every 2 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.
- Secondary Outcome Measures
Name Time Method Time to First Dose of Rescue Analgesia 48 Hours Rescue analgesia (oral oxycodone 5 mg) was available to subjects with inadequately controlled pain upon request. Time to first rescue was calculated as the elapsed time from administration of Dose 1 to the administration of the first dose of rescue analgesia.
Number of Subjects Utilizing Rescue Analgesia 48 Hours Rescue analgesia (oral oxycodone 5 mg) was available to subjects with inadequately controlled pain upon request.
Summed Pain Intensity Difference (SPID) at Other Intervals 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: 0.25, 0.5, 0.75, 1, and 2 hours post Dose 1. Thereafter pain assessments were to be recorded every 2 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.
Trial Locations
- Locations (1)
the Third XiangYa Medical Hospital of Central South University
🇨🇳Changsha, Hunan, China