Black Widow Spider Antivenin for Patients With Systemic Latrodectism
Public ClinicalTrials.gov record NCT00657540. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III Multicenter Clinical Trial of Analatro® [Antivenin Latrodectus (Black Widow) Equine Immune F(ab)2] in Patients With Systemic Latrodectism
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to test the efficacy and safety of a new antivenom called Analatro® for treating black widow spider bites in patients who present to a hospital emergency room within 24 hours of symptom onset. This study will be a phase III, multi-center, double-blind, randomized controlled study that takes place in emergency departments. The primary aim of this study is to determine the proportion of patients in which pain control was not achieved by 48 hours post treatment. Secondary aims are as follows: 1) a reduction in pain intensity at the end of the treatment phase compared to baseline; 2) the proportion of patients with a clinically significant decrease in pain intensity at 30 minutes post-treatment; 3) the proportion of patients in which drug-related adverse events occurred; and 4) to determine if serious, drug-related adverse events in Analatro-treated patients occurred at a rate greater than one in 10 (10%).
Study identification
- NCT ID
- NCT00657540
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 60 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 10 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2009
- Primary completion
- Sep 30, 2014
- Completion
- Sep 30, 2014
- Last update posted
- Apr 2, 2018
2009 – 2014
United States locations
- U.S. sites
- 16
- U.S. states
- 8
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Banner Good Samaritan Medical Center | Phoenix | Arizona | 85006 | — |
| Maricopa Medical Center | Phoenix | Arizona | 85008 | — |
| University of California Davis | Davis | California | 95616 | — |
| University California San Francisco - Fresno | Fresno | California | 93701 | — |
| University of California Irvine | Irvine | California | 92697 | — |
| Loma Linda University | Loma Linda | California | 92354 | — |
| University of California San Diego | San Diego | California | 92103 | — |
| San Diego Children's Hospital | San Diego | California | 92123 | — |
| University of Colorado Hospital | Aurora | Colorado | 80010 | — |
| Denver Health and Hospital Authority | Denver | Colorado | 80204 | — |
| Cape Coral Hospital | Cape Coral | Florida | 33990 | — |
| University of Florida, Department of Emergency Medicine | Gainesville | Florida | 32610 | — |
| LSU Health Sciences | Shreveport | Louisiana | 71106 | — |
| University of New Mexico | Albuquerque | New Mexico | 87131 | — |
| Texas Tech - West Texas Regional Poison Center | El Paso | Texas | 79905 | — |
| University of Virginia Health System | Charlottesville | Virginia | 22908 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00657540, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 2, 2018 · Synced Sep 27, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00657540 live on ClinicalTrials.gov.