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HTX-011 for Postoperative Pain in Total Knee Arthroplasty
NCT03015532Phase 2
Key facts
- Status
- Completed
- Start
- Jan 2017
- Primary completion
- Apr 2018
- Countries
- 1
- Sponsor
- Heron Therapeutics, Inc.
- Conditions
- postoperative pain
01
Overview
Phase 2, randomised, double-blind trial of bupivacaine + meloxicam in postoperative pain, sponsored by Heron Therapeutics, Inc. Primary endpoint: Mean Area Under the Curve of the Numeric Rating Scale Pain Intensity Scores at Rest Through 48 Hours Postsurgery. Started Jan 2017; status: completed.
02
Design
1 arm- Study design
- RandomizedDouble-blind
Cohort 1, Group 1: HTX-011
HTX-011 200 mg/6 mg via instillation
03
Endpoints
Primary
Mean Area Under the Curve of the Numeric Rating Scale Pain Intensity Scores at Rest Through 48 Hours Postsurgery
Secondary
Mean Area Under the Curve of the Numeric Rating Scale Pain Intensity Scores at Rest Through 72 Hours Postsurgery
Mean Total Postoperative Opioid Consumption (in Morphine Equivalents)
04
Results
Primary endpoints met
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