Evaluation of Preoperative N1539 in Colorectal Surgery
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Evaluation of the Safety and Efficacy of Preoperative N1539 In Colorectal Surgery
1 other identifier
interventional
57
1 country
10
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2017
Shorter than P25 for phase_3
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2017
CompletedStudy Start
First participant enrolled
October 24, 2017
CompletedFirst Posted
Study publicly available on registry
October 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 26, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 26, 2018
CompletedResults Posted
Study results publicly available
June 18, 2023
CompletedJune 18, 2023
May 1, 2023
11 months
October 24, 2017
May 25, 2023
May 25, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
N1539 30 mg
EXPERIMENTALN1539 (meloxicam injection for IV use) 30 mg every 24 hours
IV Placebo
PLACEBO COMPARATORIV Placebo every 24 hours
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Baudax Biolead
Study Sites (10)
Research Center
Florence, Alabama, 35630, United States
Research Center
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
Related Publications (1)
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.
PMID: 33094682DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Development
- Organization
- Baudax Bio Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2017
First Posted
October 27, 2017
Study Start
October 24, 2017
Primary Completion
September 26, 2018
Study Completion
September 26, 2018
Last Updated
June 18, 2023
Results First Posted
June 18, 2023
Record last verified: 2023-05