Status:
COMPLETED
Evaluation of Preoperative N1539 in Total Knee Arthroplasty
Lead Sponsor:
Baudax Bio
Conditions:
Pain, Postoperative
Eligibility:
All Genders
35-80 years
Phase:
PHASE3
Brief Summary
The primary objective of this study is to assess the effect of preoperative administration of N1539 on opioid consumption in subjects undergoing open unilateral total knee arthroplasty compared to pla...
Eligibility Criteria
Inclusion
- Voluntarily provide written informed consent.
- Be planned to undergo an elective, primary (no repeat arthroplasties) open unilateral total knee arthroplasty (TKA), and be expected to require IV analgesia, remain in an inpatient setting for ≥24 hours, and receive at least two doses of study drug.
- ASA physical status category 1, 2, or 3.
- Female subjects not pregnant or planning/attempting to become pregnant, not lactating; or commits to the use of an acceptable form of birth control for the duration of the study.
- Have a body mass index \<40 kg/m\^2
Exclusion
- Have a known allergy or hypersensitivity to any study treatment.
- Have a history of previous TKA.
- Has plans for a concurrent surgical procedure (eg, bilateral TKA).
- Has TKA planned to be performed under general anesthesia.
- Have a history of myocardial infarction within the preceding 12 months.
- Have, as determined by the investigator or the sponsor's medical monitor, a history or clinical manifestations of significant condition that would preclude participation.
- Have active or recent (within 6 months) gastrointestinal ulceration or bleeding.
- Have a known bleeding disorder which may be worsened with the administration of an NSAID.
- Be currently receiving treatment with oral meloxicam (Mobic®) or another NSAID within 48 hours prior to surgery.
- Have previously received N1539/IV meloxicam or received any investigational product within 30 days before dosing with study medication.
- Have undergone or be expected to undergo radiation therapy, chemotherapy, or other biological therapy for cancer treatment, within 60 days prior to screening through last follow-up.
Key Trial Info
Start Date :
February 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 21 2019
Estimated Enrollment :
194 Patients enrolled
Trial Details
Trial ID
NCT03434275
Start Date
February 19 2018
End Date
May 21 2019
Last Update
May 25 2023
Active Locations (6)
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1
Research Center
Florence, Alabama, United States, 35630
2
Research Center
Mobile, Alabama, United States, 36608
3
Research Center
Sheffield, Alabama, United States, 35660
4
Research Center
Tempe, Arizona, United States, 85284