Status:
COMPLETED
Double-Blind, Alacramyn® vs. Placebo in Pediatric Patients
Lead Sponsor:
Instituto Bioclon S.A. de C.V.
Collaborating Sponsors:
University of Arizona
Universidad Nacional Autonoma de Mexico
Conditions:
Scorpion Sting Envenomation
Eligibility:
All Genders
6-18 years
Phase:
PHASE2
PHASE3
Brief 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 ...
Detailed Description
The purpose of this Prospective, Randomized, Double-Blind, Controlled, Multicenter Treatment Protocol, phase III trial is to examine the safety and efficacy of Alacramyn® for treatment of patients env...
Eligibility Criteria
Inclusion
- Males and females of 6 months to 18 years of age
- Presenting for emergency treatment within 5 hours with clinically important systemic signs of scorpion sting envenomation.
- Signed written Informed Consent by patient or legal guardian.
- No participation in a clinical drug trial within the last month or concomitantly.
Exclusion
- Allergy to horse serum.
- Use within the past 24 hours of drugs expected to alter immune response: H1 or H2 blockers, corticosteroids.
- Use of any antivenom within the last month or concomitantly.
- Underlying medical conditions that significantly alter immune response: bone marrow suppression congenital or acquired immuno-deficiency state, chemotherapy and chronic corticosteroid use.
- Allergy to midazolam.
- More than 0.3mg/kg of body weight of midazolam administered during the hour prior to study drug infusion.
- Concurrent medical condition involving a baseline neurologic status mimicking envenomation (chorea, tardive dyskinesia, uncontrolled epilepsy).
- Pregnant and nursing women.
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2005
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00685230
Start Date
May 1 2004
End Date
October 1 2005
Last Update
June 2 2011
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Tucson Medical Center
Tucson, Arizona, United States, 85712
2
University Medical Center
Tucson, Arizona, United States, 85724