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The purpose of this study is to determine the analgesic efficacy and safety of N1539 in subjects undergoing abdominal laparoscopic surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N1539 15 mg | Experimental |
| |
| N1539 30 mg | Experimental |
| |
| Ketorolac | Active Comparator | IV |
|
| Placebo | Placebo Comparator | IV |
|
| N1539 7.5mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N1539 | Drug | IV |
| |
| N1539 |
| Measure | Description | Time Frame |
|---|---|---|
| Sum of the time-weighted pain intensity differences (SPID) as recorded on the Visual Analog Scale (VAS) from baseline (time 0) to 24 hours following the first dose of study medication (SPID 24) | 0 to 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neil Singla, MD | Lotus Clinical Research, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lotus Clinical Research LLC | Pasadena | California | 91105 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30737315 | Derived | Viscusi ER, Gan TJ, Bergese S, Singla N, Mack RJ, McCallum SW, Du W, Hobson S. Intravenous meloxicam for the treatment of moderate to severe acute pain: a pooled analysis of safety and opioid-reducing effects. Reg Anesth Pain Med. 2019 Mar;44(3):360-368. doi: 10.1136/rapm-2018-100184. Epub 2019 Feb 7. |
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| ID | Term |
|---|---|
| D020911 | Ketorolac Tromethamine |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Drug |
IV |
|
| N1539 | Drug | IV |
|
| Ketorolac Tromethamine | Drug | IV |
|
| Placebo | Drug | IV |
|
| D006571 | Heterocyclic Compounds |