The Efficacy and Safety of Aracmyn in Patients With Systemic Latrodectism
Information source: Instituto Bioclon S.A. de C.V.
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Arachnidism; Latrodectism
Intervention: widow spider antivenom (Biological); Placebo (Biological)
Phase: Phase 2
Status: Completed
Sponsored by: Instituto Bioclon S.A. de C.V. Official(s) and/or principal investigator(s): Richard C Dart, MD PhD, Principal Investigator, Affiliation: Rocky Mountain Poison and Drug Center Walter Garcia, MD, Study Director, Affiliation: Instituto Bioclon S.A. de C.V.
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: between-treatment groups difference in pain intensity (pre- and post-treatment)
Secondary outcome: between-treatment groups difference in proportion of treatment failures (absence of pain relief or return to hospital)between-treatment groups difference in incidence of drug-related adverse events.
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
Minimum age: 10 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Denver Health and Hospital Authority, Denver, Colorado 80204, United States
Additional Information
Starting date: October 2005
Last updated: June 11, 2008
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