A double-blind, randomized, controlled trial comparing the safety and effectiveness of conventional therapy with ecallantide to conventional therapy with placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
79
Administered as two 3 mL SC injections, each containing 30 mg ecallantide
Administered as one 3 mL SC injection containing 30 mg ecallantide
Administered as one 3 mL SC injection containing 10 mg ecallantide.
Safety and Efficacy of Ecallantide
Compare the proportion of patients meeting prespecified discharge criteria in the group receiving ecallantide with conventional therapy to patients receiving placebo with conventional therapy. Patients were evaluated against 6 discharge eligibility criteria at 1,2,3,4,5, and 6 hours after study drug administration or until discharged from the ER. A responder was defined as a patient meeting all six discharge eligibility criteria as below: • Improvement of edema to "a little better" or "a lot better" as assessed by health care provider using a five point scale • Stable vital signs (within an acceptable range) • Absence of stridor • Absence of dyspnea or use of accessory muscles during respiration • Absence of drooling • Able to drink without difficulty
Time frame: 6 hours
Time to Symptom Resolution Based on the Visual Analog Scale (VAS)
Compare the time to onset of symptom resolution between the ecallantide-treated and placebo-treated groups. The patient assessed severity of the angioedema attack using a VAS at baseline and following study drug administration every 15 minutes for the first 2 hours and then every 30 minutes through 6 hours post dosing or until the time of discharge from the ER (whichever occurred first). The scale ranged from "totally resolved" to "very severe".
Time frame: 6 hours
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Administered as two SC 3 mL injections
One 3 mL SC injection of matching placebo given to subjects randomized to the 30 mg ecallantide arm.
One 3 mL SC injection of matching placebo given to subjects randomized to the 10 mg ecallantide arm.
Er Med, Llc
Montgomery, Alabama, United States
Arrowhead Regional Medical Center
Colton, California, United States
University of California Los Angeles School of Medicine
Los Angeles, California, United States
University of California San Diego Mecial Center
San Diego, California, United States
Christiana Hospital, Department of Emergency Medicine
Newark, Delaware, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Tampa General Hospital
Tampa, Florida, United States
Georgia Health Sciences University
Augusta, Georgia, United States
DeKalb Medical
Decatur, Georgia, United States
University Consultants in Allergy and Immunology
Chicago, Illinois, United States
...and 29 more locations