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NCT00657540 · ClinicalTrials.gov registry record · Phase 3
Black Widow Spider Antivenin for Patients With Systemic Latrodectism
A Phase 3 study, sponsored by Instituto Bioclon S.A. de C.V..
- Completed
- Registry status
- Phase 3
- Development phase
- 60
- Enrollment target
NCT00657540: Completed Phase 3 study, sponsored by Instituto Bioclon S.A. de C.V..
NCT00657540 is a Phase 3 study that has completed, run by Instituto Bioclon S.A. de C.V.. The registered enrollment target is 60 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00657540, a Phase 3 study, has completed, sponsored by Instituto Bioclon S.A. de C.V..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 60 participants
- Enrollment target
Study Summary
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%).
Primary Outcome
The primary efficacy endpoint for this study was the number of subjects in which pain control was not achieved 48 hours post-study drug infusion as identified by treatment failure. A treatment failure was defined as a subject who did not achieve pain control during the treatment phase, up to 48 hours after Dose 1 infusion start time. Subjects were deemed treatment failures if they met one or more of the following criteria: * Subject did not complete the treatment phase due to absence of clinica
Interventions
- DRUG Saline
- DRUG Analatro
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2009-10 |
| Est. Completion | 2014-10 |
| Phase | Phase 3 |
What the finished NCT00657540 record still lists
NCT00657540 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Saline is the first listed.
NCT00657540 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00657540 about?
NCT00657540 is a clinical study titled "Black Widow Spider Antivenin for Patients With Systemic Latrodectism". 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 control...
What is the current status of trial NCT00657540?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 60 participants. The study started on 2009-10. Estimated completion is 2014-10.
What interventions are being tested in trial NCT00657540?
The interventions under investigation include: Saline (DRUG), Analatro (DRUG).
Who is sponsoring clinical trial NCT00657540?
This trial is sponsored by Instituto Bioclon S.A. de C.V., which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00657540's enrollment target sits among peer trials
60 1804th of 2000 higher than 177 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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