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NCT01599936 · ClinicalTrials.gov registry record · Phase 3
Open Label Clinical Trial of Anascorp® in Pediatric Patients With Scorpion Sting Envenomation
A Phase 3 study, sponsored by Instituto Bioclon S.A. de C.V..
- Completed
- Registry status
- Phase 3
- Development phase
- 50
- Enrollment target
NCT01599936 is a Phase 3 study that has completed, run by Instituto Bioclon S.A. de C.V.. The registered enrollment target is 50 participants.
The verdict
NCT01599936, a Phase 3 study, has completed, sponsored by Instituto Bioclon S.A. de C.V..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 50 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 thus eliminating the need to transport most rural patients and reducing hospitalization time.
Interventions
- BIOLOGICAL Anascorp
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2004-04 |
| Est. Completion | 2007-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01599936
The ClinicalTrials.gov registry entry for NCT01599936 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 50 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 1 intervention - of which Anascorp is the first listed.
NCT01599936 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01599936 about?
NCT01599936 is a clinical study titled "Open Label Clinical Trial of Anascorp® in Pediatric Patients With Scorpion Sting Envenomation". 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 NCT01599936?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 50 participants. The study started on 2004-04. Estimated completion is 2007-06.
What interventions are being tested in trial NCT01599936?
The interventions under investigation include: Anascorp (BIOLOGICAL).
Who is sponsoring clinical trial NCT01599936?
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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