Evaluation of Preoperative N1539 in Total Knee Arthroplasty
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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. |
ClinicalTrials.gov Identifier: NCT03434275 |
Recruitment Status :
Completed
First Posted : February 15, 2018
Last Update Posted : November 13, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pain, Postoperative | Drug: N1539 Drug: Placebo | Phase 3 |
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 |

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

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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.

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 ClinicalTrials.gov identifier (NCT number): NCT03434275
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 |
Responsible Party: | Baudax Bio |
ClinicalTrials.gov 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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Total Knee Arthroplasty Pain Analgesia |
N1539 Phase 3b Knee Replacement |
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 |