Pain, Postoperative
Conditions
Keywords
Total Knee Arthroplasty, Pain, Analgesia, N1539, Phase 3b, Knee Replacement
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.
Interventions
DRUGN1539
Once Daily
DRUGPlacebo
Once Daily
Sponsors
Baudax Bio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Use Hour 0-24 | Up to 24 Hours | Total use of opioid analgesia, in IV morphine equivalent dose, from Hour 0 through 24. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| N1539 30 mg N1539 (meloxicam injection for IV use) 30 mg every 24 hours
N1539: Once Daily | 93 |
| IV Placebo IV Placebo every 24 hours
Placebo: Once Daily | 88 |
| Total | 181 |
Baseline characteristics
| Characteristic | N1539 30 mg | Total | IV Placebo |
|---|---|---|---|
| Age, Continuous | 66.9 years STANDARD_DEVIATION 8.23 | 66.2 years STANDARD_DEVIATION 8.18 | 65.5 years STANDARD_DEVIATION 8.11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 18 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 84 Participants | 163 Participants | 79 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants | 35 Participants | 17 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 74 Participants | 144 Participants | 70 Participants |
| Region of Enrollment United States | 93 participants | 181 participants | 88 participants |
| Sex: Female, Male Female | 54 Participants | 105 Participants | 51 Participants |
| Sex: Female, Male Male | 39 Participants | 76 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 93 | 0 / 88 |
| other Total, other adverse events | 65 / 93 | 81 / 88 |
| serious Total, serious adverse events | 3 / 93 | 9 / 88 |
Outcome results
Primary
Opioid Use Hour 0-24
Total use of opioid analgesia, in IV morphine equivalent dose, from Hour 0 through 24.
Time frame: Up to 24 Hours
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| N1539 30 mg | Opioid Use Hour 0-24 | 18.94 mg morphine equivalent | Standard Error 1.32 |
| IV Placebo | Opioid Use Hour 0-24 | 27.73 mg morphine equivalent | Standard Error 1.371 |