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NCT00685230 · ClinicalTrials.gov registry record · Phase 2
Double-Blind, Alacramyn® vs. Placebo in Pediatric Patients
A Phase 2 study, sponsored by Instituto Bioclon S.A. de C.V..
- Completed
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
NCT00685230 is a Phase 2 study that has completed, run by Instituto Bioclon S.A. de C.V.. The registered enrollment target is 15 participants.
The verdict
NCT00685230, a Phase 2 study, has completed, sponsored by Instituto Bioclon S.A. de C.V..
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
Study Summary
There is no FDA approved therapy for the treatment of scorpion envenomation, Centruroides scorpion envenomation produces a pattern of neurotoxicity with a spectrum of severity ranging from trivial to life threatening. Patients stung by Centruroides scorpions develop a clinical syndrome which may require sedation with benzodiazepines and observation for 6 to 28 hours of intensive care monitoring. A safe therapy is necessary to halt the progression of symptoms early in the clinical course while avoiding the clinical deterioration that can occur en route to a tertiary facility. Alacramyn® is anticipated to be safer and more effective than the present standard of care, midazolam, and faster-acting such that the need for transport of most rural patients will be eliminated and will reduce hospitalization time. The working hypotheses are as follows: 1. The investigational antivenom is safe as treatment of scorpion sting envenomation. 2. The investigational antivenom is effective as treatment of scorpion sting envenomation.
Interventions
- OTHER Placebo
- BIOLOGICAL Antivenin Centruroides (scorpion) equine immune F(ab)2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2004-05 |
| Est. Completion | 2005-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00685230
The ClinicalTrials.gov registry entry for NCT00685230 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 15 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 Placebo is the first listed.
NCT00685230 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00685230 about?
NCT00685230 is a clinical study titled "Double-Blind, Alacramyn® vs. Placebo in Pediatric Patients". There is no FDA approved therapy for the treatment of scorpion envenomation, Centruroides scorpion envenomation produces a pattern of neurotoxicity with a spectrum of severity ranging from trivial to life threatening. Patients stung by Centruroides scorpions develop a clinical syndrome which may req...
What is the current status of trial NCT00685230?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2004-05. Estimated completion is 2005-10.
What interventions are being tested in trial NCT00685230?
The interventions under investigation include: Placebo (OTHER), Antivenin Centruroides (scorpion) equine immune F(ab)2 (BIOLOGICAL).
Who is sponsoring clinical trial NCT00685230?
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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