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Study of Local Administration of DepoTXA for Reduced Postsurgical Bleeding in Subjects Undergoing TKA

Total Knee Arthroplasty Clinical Trial

Official title:
A Randomized, Single-Blind, Active-Controlled, Dose-Ranging Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Local Administration of DepoTXA for Reduced Postsurgical Bleeding in Subjects Undergoing Total Knee Arthroplasty

Clinical Trial Summary

This is a Phase 2, randomized, single-blind, active-controlled dose-ranging study in subjects scheduled to undergo total knee arthroplasty (TKA).

Clinical Trial Description

Approximately 60 subjects (15 per arm) are planned for enrollment. Subjects will be randomized in a 1:1:1:1 ratio to receive either DepoTXA 400 mg, DepoTXA 800 mg, DepoTXA 1200 mg, or IV TXA (Cyklokapron® 1 gram). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02922582
Study type Interventional
Source Pacira Pharmaceuticals, Inc
Contact
Status Terminated
Phase Phase 2
Start date October 28, 2016
Completion date November 27, 2017
View Details
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