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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 is a Phase 3 study that has completed, run by Instituto Bioclon S.A. de C.V.. The registered enrollment target is 60 participants.
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%).
Interventions
- DRUG Saline
- DRUG Analatro
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2009-10 |
| Est. Completion | 2014-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00657540
The ClinicalTrials.gov registry entry for NCT00657540 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 60 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 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Saline is the first listed.
NCT00657540 reports 0 study locations.
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.
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