Pain, Postoperative
Conditions
Keywords
Colorectal surgery, Pain, Analgesia, N1539, Phase 3b
Brief summary
The primary objective of this study is to evaluate the safety and tolerability of preoperative dosing of N1539 30 mg in subjects undergoing colorectal surgery, including clinical laboratory tests, wound healing evaluation, incidence of anastomotic leaks, and incidence of Adverse Events (AEs) and Serious AEs (SAEs).
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
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Voluntarily provide written informed consent. * Be planned to undergo primary (no repeat procedures) open or laparoscopic colorectal surgery (laparoscopic expected to require a ≥ 5 cm incision) with bowel resection and/or anastomosis. * 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. * Planned surgical procedure includes a resection beyond the peritoneal reflection, is related to an acute bout of diverticulitis, or is associated with an emergency procedure. * 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, with exception of events related to an ulcerative colitis diagnosis. * 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 |
|---|---|---|
| Evaluation of Safety and Tolerability - Number of Subjects With an AE | Up to 30 days | Evaluate the incidence of adverse events in subjects receiving N1539 30 mg vs. placebo prior to colorectal surgery |
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 | 27 |
| IV Placebo IV Placebo every 24 hours
Placebo: Once Daily | 28 |
| Total | 55 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Noncompliance | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | N1539 30 mg | Total | IV Placebo |
|---|---|---|---|
| Age, Continuous | 58.8 years STANDARD_DEVIATION 11.18 | 59.7 years STANDARD_DEVIATION 11.06 | 60.6 years STANDARD_DEVIATION 11.07 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 9 Participants | 5 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 | 22 Participants | 45 Participants | 23 Participants |
| Region of Enrollment United States | 27 participants | 55 participants | 28 participants |
| Sex: Female, Male Female | 12 Participants | 23 Participants | 11 Participants |
| Sex: Female, Male Male | 15 Participants | 32 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 28 |
| other Total, other adverse events | 11 / 27 | 17 / 28 |
| serious Total, serious adverse events | 3 / 27 | 4 / 28 |
Outcome results
Primary
Evaluation of Safety and Tolerability - Number of Subjects With an AE
Evaluate the incidence of adverse events in subjects receiving N1539 30 mg vs. placebo prior to colorectal surgery
Time frame: Up to 30 days
Population: All randomized subjects
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| N1539 30 mg | Evaluation of Safety and Tolerability - Number of Subjects With an AE | 23 participants |
| IV Placebo | Evaluation of Safety and Tolerability - Number of Subjects With an AE | 26 participants |