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Evaluation of Preoperative N1539 in Total Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03434275
Recruitment Status : Completed
First Posted : February 15, 2018
Last Update Posted : November 13, 2019
Information provided by (Responsible Party):
Baudax Bio

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement
Drug Information available for: Meloxicam

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

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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03434275

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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
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Baudax Bio Identifier: NCT03434275    
Other Study ID Numbers: REC-17-025
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Phase 3b
Knee Replacement
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
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