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NCT03434275 · ClinicalTrials.gov registry record · Phase 3
Evaluation of Preoperative N1539 in Total Knee Arthroplasty
A Phase 3 study of Pain, Postoperative, sponsored by Baudax Bio.
- Completed
- Registry status
- Phase 3
- Development phase
- 194
- Enrollment target
- 6
- Study locations
NCT03434275: Completed Phase 3 study of Pain, Postoperative, sponsored by Baudax Bio.
NCT03434275 is a Phase 3 study of Pain, Postoperative that has completed, run by Baudax Bio. The registered enrollment target is 194 participants, below the 271-participant average among 113 other Pain, Postoperative trials with a reported enrollment target (28% lower). The trial reports 6 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03434275, a Phase 3 study of Pain, Postoperative, has completed, sponsored by Baudax Bio.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 194 participants
- Enrollment target
- 6
- Study locations
Study 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.
Primary Outcome
Total use of opioid analgesia, in IV morphine equivalent dose, from Hour 0 through 24.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG N1539
Study Locations (6)
Alabama
- Research Center - Florence
- Research Center - Mobile
- Research Center - Sheffield
Florida
- Research Center - Tamarac
- Research Center - Vero Beach
Arizona
- Research Center - Tempe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 194 participants |
| Start Date | 2018-02-19 |
| Est. Completion | 2019-05-21 |
| Phase | Phase 3 |
What the finished NCT03434275 record still lists
NCT03434275 is an interventional study that assigns participants to a tested intervention. The registered 194 participants enrollment target is mid-sized for trials with a published cap, below the 271-participant average among 113 other Pain, Postoperative trials with a reported enrollment target (28% lower).
The record links to 1 condition, with Pain, Postoperative appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03434275 lists 6 locations in 3 states (Alabama, Florida, Arizona).
Frequently Asked Questions
What is clinical trial NCT03434275 about?
NCT03434275 is a clinical study titled "Evaluation of Preoperative N1539 in Total Knee Arthroplasty". 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.
What is the current status of trial NCT03434275?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 194 participants. The study started on 2018-02-19. Estimated completion is 2019-05-21.
What conditions does trial NCT03434275 study?
This clinical trial studies the following conditions: Pain, Postoperative.
What interventions are being tested in trial NCT03434275?
The interventions under investigation include: Placebo (DRUG), N1539 (DRUG).
Who is sponsoring clinical trial NCT03434275?
This trial is sponsored by Baudax Bio, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03434275 being conducted?
This trial has 6 study locations across Alabama, Arizona, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pain, Postoperative
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03434275's enrollment target sits among peer trials
194 20th of 113 higher than 94 of 113 other Pain, Postoperative trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pain, Postoperative trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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