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The Efficacy and Safety of Aracmyn in Patients With Systemic Latrodectism

This study has been completed.
Sponsor:
Information provided by:
Instituto Bioclon S.A. de C.V.
ClinicalTrials.gov Identifier:
NCT00247078
First received: October 28, 2005
Last updated: June 11, 2008
Last verified: June 2008
  Purpose

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.

Condition Intervention Phase
Arachnidism
Latrodectism
Biological: widow spider antivenom
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Instituto Bioclon S.A. de C.V.:

Primary Outcome Measures:
  • between-treatment groups difference in pain intensity (pre- and post-treatment) [ Time Frame: within first two hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • between-treatment groups difference in incidence of drug-related adverse events. [ Time Frame: onset of adverse events within 21 days ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: October 2005
Study Completion Date: December 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Analatro
Placebo Comparator: 2
Patients with moderate to severe pain due to Black Widow envenomation
Biological: Placebo

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.

  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00247078

Locations
United States, Colorado
Denver Health and Hospital Authority
Denver, Colorado, United States, 80204
Sponsors and Collaborators
Instituto Bioclon S.A. de C.V.
Investigators
Principal Investigator: Richard C Dart, MD PhD Rocky Mountain Poison and Drug Center
Study Director: Walter Garcia, MD Instituto Bioclon S.A. de C.V.
  More Information

No publications provided

Responsible Party: Walter Garcia, MD, Instituto Bioclon
ClinicalTrials.gov Identifier: NCT00247078     History of Changes
Other Study ID Numbers: AR-03/02
Study First Received: October 28, 2005
Last Updated: June 11, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Instituto Bioclon S.A. de C.V.:
black
widow
spider
antivenom

Additional relevant MeSH terms:
Antivenins
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 24, 2014