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Evaluation of Preoperative N1539 in Total Knee Arthroplasty

NCT03434275 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2023-05-25

Study results available
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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

  • Pain, Postoperative

Interventions

DRUG

N1539

Once Daily

DRUG

Placebo

Once Daily

Sponsors & Collaborators

  • Baudax Bio

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-19
Primary Completion
2019-05-21
Completion
2019-05-21
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03434275 on ClinicalTrials.gov