Research Study Summary
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Evaluation of the Safety of N1539 Following Major Surgery
This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, evaluation of the safety of N1539 in adult subjects undergoing major surgery.
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CW ID: 216182
Date Last Changed:
June 16, 2016
Clinical Trial Snapshot
- Both Male and Female
- 18 to 80 Years
- Overall Status
- Recro Pharma
- Facility Type
- Subject must be planned to undergo major elective surgery, and be expected to require intravenous analgesia and remain in an inpatient setting for at least 48 hours.
- Have a body mass index ≤38 kg/m2
- Have a known allergy or hypersensitivity to meloxicam or any excipient of N1539, aspirin, or other non-steroidal anti-inflammatory drugs (NSAIDs).
- Be scheduled to undergo cranial surgery, open heart procedure, any type of coronary artery bypass graft, organ transplant, cancer related surgery, or any other surgical procedure in which NSAIDs are contraindicated.
- Planned or actual admission to the intensive care unit at any time during study participation.
- Have a history of myocardial infarction within the preceding 12 months.
- Have history of or positive test results for HIV, or hepatitis B or C.
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