Trials / Completed
CompletedNCT03323385
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 57 (actual)
- Sponsor
- Baudax Bio · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | N1539 | Once Daily |
| DRUG | Placebo | Once Daily |
Timeline
- Start date
- 2017-10-24
- Primary completion
- 2018-09-26
- Completion
- 2018-09-26
- First posted
- 2017-10-27
- Last updated
- 2023-06-18
- Results posted
- 2023-06-18
Locations
10 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03323385. Inclusion in this directory is not an endorsement.