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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 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 108 other Pain, Postoperative trials with a reported enrollment target (28% lower). The trial reports 6 study locations across 3 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03434275
The ClinicalTrials.gov registry entry for NCT03434275 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 194 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 271-participant average among 108 other Pain, Postoperative trials with a reported enrollment target (28% lower). The listed sponsor is Baudax Bio, which has 11 total studies on file at ClinicalTrials.gov.
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 reports 6 study locations spanning 3 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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