drugset / Trial / NCT01084161
Study to Evaluate the Efficacy, Safety and Tolerability of N1539
RandomizedParallel-groupTriple-blindTreatment
Summary
To determine the analgesic efficacy, duration of effect, and safety of single doses of N1539 in subjects undergoing open abdominal hysterectomy
Timeline
- Start
- 2010-03
- Primary completion
- 2011-01
- Completion
- 2011-01
Publications
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Meloxicam | Small molecule | 5 mg | Intravenous |
| Subject | Meloxicam | Small molecule | 7.5 mg | Intravenous |
| Subject | Meloxicam | Small molecule | 15 mg | Intravenous |
| Subject | Meloxicam | Small molecule | 30 mg | Intravenous |
| Subject | Meloxicam | Small molecule | 60 mg | Intravenous |
| Comparator | Morphine | Other / unclassified | 10 mg | Intravenous |
| Comparator | Morphine | Other / unclassified | 15 mg | Intravenous |
Indications
No indication recorded.