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To determine the analgesic efficacy, duration of effect, and safety of single doses of N1539 in subjects undergoing open abdominal hysterectomy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N1539 5 mg | Experimental |
| |
| N1539 7.5 mg | Experimental |
| |
| N1539 15 mg | Experimental |
| |
| N1539 30 mg | Experimental |
| |
| N1539 60 mg | Experimental |
| |
| Placebo | Placebo Comparator |
| |
| morphine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N1539 | Drug | 5 mg IV once per day |
| |
| N1539 |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the analgesic efficacy, duration of effect and safety of single doses of IV N1539 as measured by the SPID (summary of pain intensity) and TOPAR (summary of the time-weighted pain relief scores) from 0-24 hours. | Additionally, to determine the efficacy seen within the first hour after study drug administration, as measured by the SPID 0-60 minutes post-dose. | at 60 minutes post dose and at 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety and tolerability of IV N1539 by laboratory data, vital signs, wound site evaluation and Adverse Events | 5-7 days post initial dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tbilisi | 0159 | Georgia | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31094806 | Derived | Rechberger T, Mack RJ, McCallum SW, Du W, Freyer A. Analgesic Efficacy and Safety of Intravenous Meloxicam in Subjects With Moderate-to-Severe Pain After Open Abdominal Hysterectomy: A Phase 2 Randomized Clinical Trial. Anesth Analg. 2019 Jun;128(6):1309-1318. doi: 10.1213/ANE.0000000000003920. | |
| 30737315 | Derived |
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| ID | Term |
|---|---|
| D009020 | Morphine |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| Drug |
7.5 mg IV once per day |
|
| N1539 | Drug | 15 mg IV once per day |
|
| N1539 | Drug | 30 mg IV once per day |
|
| placebo | Drug | IV placebo once per day |
|
| Morphine | Drug | morphine 10-15 mg IV once per day |
|
| N1539 | Drug | 60 mg IV once per day |
|
| Tbilisi |
| 0186 |
| Georgia |
| Bialystok | 15-276 | Poland |
| Gdansk | 80-402 | Poland |
| Lodz | 94-029 | Poland |
| Lublin | 20-081 | Poland |
| Poznan | 60-535 | Poland |
| Ruda Śląska | 41-703 | Poland |
| Szczecin | 70-111 | Poland |
| Belgrade | 11000 | Serbia |
| Kragujevac | 34000 | Serbia |
| Novi Sad | 21000 | Serbia |
| 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. |
| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |