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
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)
Yangtze River Pharmaceutical Group Co., Ltd. is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Participants with the following cardiovascular diseases or history:
Drug: Meloxicam Injection
Drug: Sodium Chloride Injection
Intravenous meloxicam Injection, 30mg every 24 hours, for a total of 2 doses
Intravenous Sodium Chloride Injection, 18mg every 24 hours, for a total of 2 doses
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
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
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
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
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
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
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
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
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Meloxicam
Yangtze River Pharmaceutical Group Co., Ltd.