Status:
COMPLETED
The Efficacy and Safety of Aracmyn in Patients With Systemic Latrodectism
Lead Sponsor:
Instituto Bioclon S.A. de C.V.
Collaborating Sponsors:
Rocky Mountain Poison and Drug Center
Conditions:
Arachnidism
Latrodectism
Eligibility:
All Genders
10+ years
Phase:
PHASE2
Brief 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 wit...
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 antiveno...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00247078
Start Date
October 1 2005
End Date
December 1 2006
Last Update
March 22 2016
Active Locations (1)
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1
Denver Health and Hospital Authority
Denver, Colorado, United States, 80204