CompletedPhase 2

The Efficacy and Safety of Aracmyn in Patients With Systemic Latrodectism

United States24 participantsStarted 2005-10

Plain-language 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.

Who can participate

Age range10 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

between-treatment groups difference in pain intensity (pre- and post-treatment)

Timeframe: within first two hours

Trial details

NCT IDNCT00247078

SponsorInstituto Bioclon S.A. de C.V.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2006-10

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