Clinical trial NCT03434275: Evaluation of Preoperative N1539 in Total Knee Arthroplasty
Official title: A Phase 3b, Randomized, Double-Blind, Placebo-Control, Multicenter, Evaluation of the Safety and Efficacy of N1539 Administered Preoperatively in Open Unilateral Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain, Postoperative
Keywords: Total Knee Arthroplasty
Pain
Analgesia
N1539
Phase 3b
Knee Replacement
Lead sponsor: Baudax Bio
Sponsor class: INDUSTRY
First posted: 2018-02-15
Enrollment: 194
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 placebo.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Opioid Use Hour 0-24
timeFrame: Up to 24 Hours
Secondary outcomes:
Other outcomes:
Locations:
city: Florence
country: United States
facility: Research Center
state: Alabama
city: Mobile
country: United States
facility: Research Center
state: Alabama
city: Sheffield
country: United States
facility: Research Center
state: Alabama
city: Tempe
country: United States
facility: Research Center
state: Arizona
city: Tamarac
country: United States
facility: Research Center
state: Florida
city: Vero Beach
country: United States
facility: Research Center
state: Florida
Study officials:
References:
citation: Berkowitz RD, Steinfeld R, Sah AP, Mack RJ, McCallum SW, Du W, Black LK, Freyer A, Coyle E. Safety and Efficacy of Perioperative Intravenous Meloxicam for Moderate-to-Severe Pain Management in Total Knee Arthroplasty: A Randomized Clinical Trial. Pain Med. 2021 Jun 4;22(6):1261-1271. doi: 10.1093/pm/pnab016.