Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meloxicam Nanocrystal Injection | Experimental | The eligible subjects will receive Meloxicam Nanocrystal Injection, administered as 30 mg (1 mL) every 24 h for 2 doses. |
|
| Placebo | Placebo Comparator | The eligible subjects will receive Placebo, administered as 1 mL Placebo every 24 h for 2 doses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meloxicam Nanocrystal Injection | Drug | 30 mg (1 mL), once daily, by intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Chen xiangdong | Union Hospital of Tongji Medical College of Huazhong University of Science and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Union Hospital of Tongji Medical College of Huazhong University of Science and Technology | Wuhan | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | 1 mL Placebo, once daily, by intravenous infusion |
|
| 0-48 hours after the first dose |
| 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. | 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 |
| The total amount of remedial analgesia used 24 h and 48 h after the first dose | 0-48 hours after the first dose |
| 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. | 48 hours after the first dose |
| 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. | 48 hours after the first dose |