NCT02922582

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Pacira Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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).

Conditions

• Total Knee Arthroplasty

Interventions

Type	Name	Description
DRUG	DepoTXA
DRUG	Tranexamic Acid

Timeline

• Start date: 2016-10-28
• Primary completion: 2017-11-27
• Completion: 2017-11-27
• First posted: 2016-10-04
• Last updated: 2020-12-11
• Results posted: 2020-12-11

Locations

5 sites across 1 country: United States