NCT00247078

The Efficacy and Safety of Aracmyn in Patients With Systemic Latrodectism

The Efficacy and Safety of Aracmyn® [Antivenin Latrodectus (Black Widow)Equine Immune F(ab)2], in Patients With Systemic Latrodectism: A Phase II, Multi-center, Randomized, Double-Blind Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Instituto Bioclon S.A. de C.V. · Industry
• Sex: All
• Age: 10 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the safety and effectiveness of an investigational antivenom and the current standard of care (pain management with opioid analgesics) for treating patients with a widow spider bite. The working hypotheses are as follows: 1. the investigational antivenom is more promptly effective at alleviating the pain associated with a widow spider bite than routine management with opioid pain medication 2. the investigational antivenom is as safe a treatment as opioid pain medication in treating patients with a widow spider bite.

Detailed description

The purpose of this randomized, double-blind, multi-center phase II trial is to examine the safety and efficacy of Aracmyn® \[Antivenin Latrodectus (Black Widow) Equine Immune F(ab)2\], a new antivenom, for treatment of patients envenomed by the widow spider. Twenty-four subjects will be randomized to receive either the study drug or control (normal saline) through intravenous (IV) infusion. Following infusion, subjects will be monitored for changes in pain and clinical signs during a two-hour observation period. A standard dose of IV fentanyl will be offered to all subjects as pain medication at specific intervals following treatment. Vital signs, blood samples, and pain intensity scores (using a visual analog scale, VAS) will be collected before and after the infusion, as well as during the observation period. This study uses a treatment failure protocol, which involves administration of Merck Antivenin to subjects who do not obtain adequate pain relief from the study drug or control. Primary efficacy and safety endpoints for this 12-month trial will be improvement in pain intensity and clinical signs and incidence of adverse events, respectively.

Conditions

• Arachnidism
• Latrodectism

Interventions

Type	Name	Description
BIOLOGICAL	widow spider antivenom	3 vials of antivenom capable of neutralizing 600 LD50 of L. mactans
BIOLOGICAL	Placebo

Timeline

• Start date: 2005-10-01
• Primary completion: 2006-10-01
• Completion: 2006-12-01
• First posted: 2005-11-01
• Last updated: 2016-03-22

Locations

1 site across 1 country: United States