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COMPLETED Phase 3

Evaluation of Preoperative N1539 in Total Knee Arthroplasty

NCT03434275 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 194 participants
Start Date 2018-02-19
Est. Completion 2019-05-21
Phase Phase 3

Sponsor

Baudax Bio

3 total trials

Interested in This Trial?

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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 194 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baudax Bio, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03434275 reports 6 study locations spanning 3 distinct geographic areas — top geographies include Alabama, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03434275?

The interventions under investigation include: Placebo (DRUG), N1539 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03434275?

This trial is sponsored by Baudax Bio, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial