Analatro Black Widow Spider Antivenin for Patients with Systemic Latrodectism
Location(s): United States
The purpose of this study is to test the effectiveness 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 is a phase III, multi-center, double-blind, randomized controlled study that takes place in emergency departments. The primary aim 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%).