Randomized Controlled Trial to Compare Two Anti-scorpion Serums
NCT ID: NCT00739440
Last Updated: 2013-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
120 participants
INTERVENTIONAL
2008-08-31
2008-11-30
Brief Summary
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Detailed Description
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This is a randomized clinical trial, which included 120 subjects of both sexes aged 15 and 60 years old and residents of the state of Guanajuato, divided into 2 groups: 60 patients received antiscorpion serum of Birmex and 60 patients receive other commercial serum.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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I
Patients 15 to 60 years with scorpion sting, will receive serum antiscorpion elaborated by Birmex
serum antiscorpion
The dose may be required for the patient according to clinical manifestations and evolution
II
Patients 15 to 60 years with scorpion sting, will receive other commercial serum antiscorpion (Alacramyn)
serum antiscorpion
The dose may be required for the patient according to clinical manifestations and evolution
Interventions
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serum antiscorpion
The dose may be required for the patient according to clinical manifestations and evolution
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Informed consent
* Age 15-60
* Either sex
* Resident in study area
Exclusion Criteria
* Blood transfusion at any stage of life
* Sensitivity or intolerance to serums antiscorpion or horse products
* Pregnancy
* Some immunodeficiency
15 Years
60 Years
ALL
No
Sponsors
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Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.
OTHER
Responsible Party
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Principal Investigators
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Jimenez C Ma. Eugenia, PhD
Role: PRINCIPAL_INVESTIGATOR
Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.
Other Identifiers
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Birmex-01-2008
Identifier Type: -
Identifier Source: org_study_id