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The Efficacy and Safety of Aracmyn in Patients With Systemic Latrodectism
NCT00247078 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL widow spider antivenom
Study Locations (1)
Colorado
- Denver Health and Hospital Authority — Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2005-10 |
| Est. Completion | 2006-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00247078
The ClinicalTrials.gov registry entry for NCT00247078 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Instituto Bioclon S.A. de C.V., which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Arachnidism appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00247078 reports 1 study location spanning 1 distinct geographic area — top geographies include Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00247078 about?
NCT00247078 is a clinical study titled "The Efficacy and Safety of Aracmyn in Patients With Systemic Latrodectism". 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 m...
What is the current status of trial NCT00247078?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2005-10. Estimated completion is 2006-12.
What conditions does trial NCT00247078 study?
This clinical trial studies the following conditions: Arachnidism, Latrodectism. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00247078?
The interventions under investigation include: Placebo (BIOLOGICAL), widow spider antivenom (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00247078?
This trial is sponsored by Instituto Bioclon S.A. de C.V., which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00247078 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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