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Black Widow Spider Antivenin for Patients With Systemic Latrodectism

NCT00657540 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-04-03

Study results available
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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%).

Conditions

  • Latrodectism

Interventions

DRUG

Analatro

30 mL of lyophilized antivenom, reconstituted in 50 mL saline infused over 10 minutes, up to 2 doses

DRUG

Saline

50 mL of saline infused over 10 minutes

Sponsors & Collaborators

  • Rare Disease Therapeutics Inc.

    collaborator OTHER

  • Instituto Bioclon S.A. de C.V.

    lead INDUSTRY

Principal Investigators

  • Richard C Dart, MD, PhD · Rocky Mountain Poison & Drug Center - Denver Health

  • 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
2009-10-31
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • United States

Study Locations

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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 NCT00657540 on ClinicalTrials.gov