Evaluation of Preoperative N1539 in Total Knee Arthroplasty

• ClinicalTrials.gov Identifier: NCT03434275
• Recruitment Status: Completed
• First Posted: February 15, 2018
• Last Update Posted: November 13, 2019
• Sponsor: Baudax Bio
• Information provided by (Responsible Party): Baudax Bio

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pain, Postoperative	Drug: N1539; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 194 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: February 19, 2018
• Actual Primary Completion Date: May 21, 2019
• Actual Study Completion Date: May 21, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: N1539 30 mg; N1539 (meloxicam injection for IV use) 30 mg every 24 hours	Drug: N1539; Once Daily; Other Name: Intravenous meloxicam
Placebo Comparator: IV Placebo; IV Placebo every 24 hours	Drug: Placebo; Once Daily; Other Name: Intravenous placebo

Outcome Measures

Primary Outcome Measures :

1. Opioid Use Hour 0-24 [ Time Frame: Up to 24 Hours ]
   Total use of opioid analgesia, in IV morphine equivalent dose, from Hour 0 through 24.

Eligibility Criteria

• Ages Eligible for Study: 35 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Alabama

Research Center

Florence, Alabama, United States, 35630

Research Center

Mobile, Alabama, United States, 36608

Research Center

Sheffield, Alabama, United States, 35660

United States, Arizona

Research Center

Tempe, Arizona, United States, 85284

United States, Florida

Research Center

Tamarac, Florida, United States, 33321

Research Center

Vero Beach, Florida, United States, 32960

Sponsors and Collaborators

Baudax Bio

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Baudax Bio
• ClinicalTrials.gov Identifier: NCT03434275
• Other Study ID Numbers: REC-17-025
• First Posted: February 15, 2018
• Last Update Posted: November 13, 2019
• Last Verified: November 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Baudax Bio:

Total Knee Arthroplasty; Pain; Analgesia; N1539; Phase 3b; Knee Replacement

Additional relevant MeSH terms:

Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Meloxicam; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase 2 Inhibitors; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action