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NCT03323385 · ClinicalTrials.gov registry record · Phase 3
Evaluation of Preoperative N1539 in Colorectal Surgery
A Phase 3 study, sponsored by Baudax Bio.
- Completed
- Registry status
- Phase 3
- Development phase
- 57
- Enrollment target
NCT03323385 is a Phase 3 study that has completed, run by Baudax Bio. The registered enrollment target is 57 participants.
The verdict
NCT03323385, a Phase 3 study, has completed, sponsored by Baudax Bio.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 57 participants
- Enrollment target
Study 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
- DRUG Placebo
- DRUG N1539
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2017-10-24 |
| Est. Completion | 2018-09-26 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03323385
The ClinicalTrials.gov registry entry for NCT03323385 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baudax Bio, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03323385 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03323385 about?
NCT03323385 is a clinical study titled "Evaluation of Preoperative N1539 in Colorectal Surgery". 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 Ser...
What is the current status of trial NCT03323385?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 57 participants. The study started on 2017-10-24. Estimated completion is 2018-09-26.
What interventions are being tested in trial NCT03323385?
The interventions under investigation include: Placebo (DRUG), N1539 (DRUG).
Who is sponsoring clinical trial NCT03323385?
This trial is sponsored by Baudax Bio, which has 11 total clinical trials registered on ClinicalTrials.gov.
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