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The Efficacy and Safety of Aracmyn in Patients With Systemic Latrodectism

NCT00247078 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2016-03-22

No results posted yet for this study

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.

Conditions

  • Arachnidism
  • Latrodectism

Interventions

BIOLOGICAL

widow spider antivenom

3 vials of antivenom capable of neutralizing 600 LD50 of L. mactans

BIOLOGICAL

Placebo

Sponsors & Collaborators

  • Rocky Mountain Poison and Drug Center

    collaborator UNKNOWN

  • Instituto Bioclon S.A. de C.V.

    lead INDUSTRY

Principal Investigators

  • Richard C Dart, MD PhD · Rocky Mountain Poison and Drug Center

  • Walter Garcia, MD · Instituto Bioclon S.A. de C.V.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2006-10-31
Completion
2006-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00247078 on ClinicalTrials.gov