Black Widow Spider Antivenin for Patients With Systemic Latrodectism
Status:
Completed
Trial end date:
2014-10-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to test the efficacy and safety of a new antivenom called
Analatro® for treating black widow spider bites in patients who present to a hospital
emergency room within 24 hours of symptom onset. This study will be a phase III,
multi-center, double-blind, randomized controlled study that takes place in emergency
departments. The primary aim of this study is to determine the proportion of patients in
which pain control was not achieved by 48 hours post treatment. Secondary aims are as
follows: 1) a reduction in pain intensity at the end of the treatment phase compared to
baseline; 2) the proportion of patients with a clinically significant decrease in pain
intensity at 30 minutes post-treatment; 3) the proportion of patients in which drug-related
adverse events occurred; and 4) to determine if serious, drug-related adverse events in
Analatro-treated patients occurred at a rate greater than one in 10 (10%).