The Efficacy and Safety of Aracmyn in Patients With Systemic Latrodectism

March 18, 2016 updated by: Instituto Bioclon S.A. de C.V.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80204
        • Denver Health and Hospital Authority

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patient presents for treatment within 72 hours from time of symptoms onset
  • clinical diagnosis of widow spider envenomation
  • patient has moderate to severe pain intensity

Exclusion Criteria:

  • history of significant cardiac, respiratory, hepatic, or renal disease
  • distracting injury or chronic pain syndrome that would obscure pain intensity assessment
  • history of asthma or known sensitivity to fentanyl, morphine, diazepam, or equine serum
  • pregnant or lactating

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Patients with moderate or severe pain due to Black Widow envenomation
Biological: widow spider antivenom
3 vials of antivenom capable of neutralizing 600 LD50 of L. mactans
Other Names:
  • Analatro
Placebo Comparator: 2
Patients with moderate to severe pain due to Black Widow envenomation
Biological: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
between-treatment groups difference in pain intensity (pre- and post-treatment)
Time Frame: within first two hours
within first two hours

Secondary Outcome Measures

Outcome Measure
Time Frame
between-treatment groups difference in proportion of treatment failures (absence of pain relief or return to hospital)
Time Frame: within 24 hours after discharge from emergency department
within 24 hours after discharge from emergency department
between-treatment groups difference in incidence of drug-related adverse events.
Time Frame: onset of adverse events within 21 days
onset of adverse events within 21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Bioclon S.A. de C.V.

Collaborators

Rocky Mountain Poison and Drug Center

Investigators

  • Principal Investigator: Richard C Dart, MD PhD, Rocky Mountain Poison and Drug Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

October 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

October 28, 2005

First Submitted That Met QC Criteria

October 28, 2005

First Posted (Estimate)

November 1, 2005

Study Record Updates

Last Update Posted (Estimate)

March 22, 2016

Last Update Submitted That Met QC Criteria

March 18, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AR-03/02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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