A Phase 3 interventional study of N1539 and Placebo in Pain, Postoperative, sponsored by Baudax Bio. Completed at 10 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-06-18.
Sponsored by Baudax Bio · Phase 3, Interventional, and Treatment
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).
5,224 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.
This study's enrollment of 57 is below the median of 75 across 4,457 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Baudax Bio is the lead sponsor of 11 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
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N1539 (meloxicam injection for IV use) 30 mg every 24 hours
Drug: N1539
IV Placebo every 24 hours
Drug: Placebo
Once Daily
Also known as: Intravenous meloxicam
Once Daily
Also known as: Intravenous placebo
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
| Milestone | N1539 30 mg | IV Placebo |
|---|---|---|
| Started | 27 | 30 |
| Dosed | 27 | 28 |
| Completed | 26 | 27 |
| Not completed | 1 | 3 |
| Withdrew: Withdrawal by subject | 1 | 2 |
| Withdrew: Noncompliance | 0 | 1 |
Evaluate the incidence of adverse events in subjects receiving N1539 30 mg vs. placebo prior to colorectal surgery
| participants | N1539 30 mg | IV Placebo |
|---|---|---|
| Evaluation of Safety and Tolerability - Number of Subjects With an AE | 23 | 26 |
Collected over 30 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| N1539 30 mg | 0/27 (0%) | 3/27 (11.1%) | 11/27 (40.7%) |
| IV Placebo | 0/28 (0%) | 4/28 (14.3%) | 17/28 (60.7%) |
| Event | N1539 30 mg | IV Placebo |
|---|---|---|
| IleusGastrointestinal disorders | 1/27 | 2/28 |
| Incision site cellulitisInfections and infestations | 1/27 | 0/28 |
| Wound dehiscenceInjury, poisoning and procedural complications | 1/27 | 0/28 |
| Urinary retentionRenal and urinary disorders | 1/27 | 0/28 |
| HypoglycaemiaMetabolism and nutrition disorders | 0/27 | 1/28 |
| Paranasal sinus benign neoplasmNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/27 | 1/28 |
| Event | N1539 30 mg | IV Placebo |
|---|---|---|
| NauseaGastrointestinal disorders | 9/27 | 14/28 |
| VomitingGastrointestinal disorders | 5/27 | 5/28 |
| IleusGastrointestinal disorders | 1/27 | 5/28 |
| Urinary retentionRenal and urinary disorders | 2/27 | 0/28 |
| ConstipationGastrointestinal disorders | 1/27 | 2/28 |
All randomized subjects
| Age, Continuous(years) | N1539 30 mg | IV Placebo | Total |
|---|---|---|---|
| Mean | 58.8 ± 11.18 | 60.6 ± 11.07 | 59.7 ± 11.06 |
| Sex: Female, Male(Participants) | N1539 30 mg | IV Placebo | Total |
|---|---|---|---|
| Female | 12 | 11 | 23 |
| Male | 15 | 17 | 32 |
| Race (NIH/OMB)(Participants) | N1539 30 mg | IV Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 4 | 5 | 9 |
| White | 22 | 23 | 45 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | N1539 30 mg | IV Placebo | Total |
|---|---|---|---|
| United States | 27 | 28 | 55 |
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Studies of the drug tested here: Meloxicam
Baudax Bio