The Efficacy and Safety of Aracmyn in Patients With Systemic Latrodectism

Completed · Phase 2 · Has a placebo group

Conditions studied: Arachnidism, Latrodectism

In brief

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.

Key facts

Study ID

NCT00247078

Run by

Instituto Bioclon S.A. de C.V.

People needed

24

Starts

2005-10-01

Expected to finish

2006-12-01

Last updated by the study team

2016-03-22

Who can join

Age: 10 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.