Trials / Completed
CompletedNCT03434275
Evaluation of Preoperative N1539 in Total Knee Arthroplasty
A Phase 3b, Randomized, Double-Blind, Placebo-Control, Multicenter, Evaluation of the Safety and Efficacy of N1539 Administered Preoperatively in Open Unilateral Total Knee Arthroplasty
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 194 (actual)
- Sponsor
- Baudax Bio · Industry
- Sex
- All
- Age
- 35 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to assess the effect of preoperative administration of N1539 on opioid consumption in subjects undergoing open unilateral total knee arthroplasty compared to placebo.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | N1539 | Once Daily |
| DRUG | Placebo | Once Daily |
Timeline
- Start date
- 2018-02-19
- Primary completion
- 2019-05-21
- Completion
- 2019-05-21
- First posted
- 2018-02-15
- Last updated
- 2023-05-25
- Results posted
- 2023-05-25
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03434275. Inclusion in this directory is not an endorsement.