Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N1539 30 mg | Experimental | N1539 (meloxicam injection for IV use) 30 mg every 24 hours |
|
| IV Placebo | Placebo Comparator | IV Placebo every 24 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N1539 | Drug | Once Daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 30 days |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Center | Florence | Alabama | 35630 | United States | ||
| Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33094682 | Derived | Silinsky JD, Marcet JE, Anupindi VR, Karkare SU, Shah DR, Mack RJ, McCallum SW, Du W, Freyer A, Black LK. Preoperative intravenous meloxicam for moderate-to-severe pain in the immediate post-operative period: a Phase IIIb randomized clinical trial in 55 patients undergoing primary open or laparoscopic colorectal surgery with bowel resection and/or anastomosis. Pain Manag. 2021 Jan;11(1):9-21. doi: 10.2217/pmt-2020-0061. Epub 2020 Oct 23. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | N1539 30 mg | N1539 (meloxicam injection for IV use) 30 mg every 24 hours N1539: Once Daily |
| FG001 | IV Placebo | IV Placebo every 24 hours Placebo: Once Daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All randomized subjects
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | N1539 30 mg | N1539 (meloxicam injection for IV use) 30 mg every 24 hours N1539: Once Daily |
| BG001 | IV Placebo | IV Placebo every 24 hours Placebo: Once Daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | All randomized subjects | Posted | Number | participants | Up to 30 days |
|
30 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | N1539 30 mg | N1539 (meloxicam injection for IV use) 30 mg every 24 hours N1539: Once Daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ileus | Gastrointestinal disorders | MedDRA (20.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (20.1) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Development | Baudax Bio Inc. | 484-395-2440 | info@baudaxbio.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 16, 2017 | Apr 28, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 30, 2019 | Apr 28, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D010146 | Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Once Daily |
|
|
| Mobile |
| Alabama |
| 36605 |
| United States |
| Research Center | Miami | Florida | 33136 | United States |
| Research Center | Tampa | Florida | 33606 | United States |
| Research Center | Metairie | Louisiana | 70006 | United States |
| Research Center | Jackson | Mississippi | 39202 | United States |
| Research Center | Cleveland | Ohio | 44111 | United States |
| Research Center | Cleveland | Ohio | 44195 | United States |
| Research Center | Columbus | Ohio | 43210 | United States |
| Research Center | Philadelphia | Pennsylvania | 19140 | United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| 0 |
| 27 |
| 3 |
| 27 |
| 11 |
| 27 |
| EG001 | IV Placebo | IV Placebo every 24 hours Placebo: Once Daily | 0 | 28 | 4 | 28 | 17 | 28 |
| Incision site cellulitis | Infections and infestations | MedDRA (20.1) | Non-systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA (20.1) | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Non-systematic Assessment |
|
| Paranasal sinus benign neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA (20.1) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (20.1) | Non-systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA (20.1) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (20.1) | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA (20.1) | Non-systematic Assessment |
|
Discussion and/or publication of data generated is not permitted without the prior written consent of the sponsor.
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |