Clinical Trial Details

Overview

Research Study Summary

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Evaluation of the Safety of N1539 Following Major Surgery

Purpose

This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, evaluation of the safety of N1539 in adult subjects undergoing major surgery.

To Learn more

CW ID: 216182
Date Last Changed: June 16, 2016

Clinical Trial Snapshot

Gender
Both Male and Female
Age
18 to 80 Years
Overall Status
Recruiting
Lead Sponsor
Recro Pharma
Facility Type
N/A

Eligibility

Inclusion Criteria:
  • 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
Exclusion Criteria:
  • 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.

Contact

Rachel Karlnoski
University of South Florida - South Tampa Center for Advanced Healthcare
2 Tampa General Circle
Tampa, FL 33606
Phone: 813-844-4133

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