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Randomized Controlled Trial to Compare Two Anti-Scorpion Serums

This study has been completed.
Sponsor:
Information provided by:
Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.
ClinicalTrials.gov Identifier:
NCT00739440
First received: August 19, 2008
Last updated: November 14, 2008
Last verified: November 2008
History of Changes

August 19, 2008
November 14, 2008
August 2008
October 2008   (final data collection date for primary outcome measure)
Measuring of IgG, IgM, IgE [ Time Frame: baseline and 12 hrs ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00739440 on ClinicalTrials.gov Archive Site
Security of treatment [ Time Frame: baseline and 12 hrs ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Randomized Controlled Trial to Compare Two Anti-Scorpion Serums
Randomized Controlled Trial to Evaluate Efficiency and Safety of the Polyvalent Antiscorpion Serum of Birmex Versus Other Commercial Serum

The purpose of this study is to compare the efficiency and safety of the treatment against sting scorpion, using two serums, one elaborated by Birmex versus other commercial serum

We consider relevant conduct this study because the poisoning scorpion bite represents a public health problem.

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.

We evaluate the production of IgG, IgM and IgE through ELISA in baseline measurement and at 12 pm. It will evaluate the levels of IgG, IgM and IgE comparing the treatment groups.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Insect Bites
Drug: serum antiscorpion
The dose may be required for the patient according to clinical manifestations and evolution
Other Name: serum antiscorpion
  • Experimental: I
    Patients 15 to 60 years, will receive serum elaborated by Birmex
    Intervention: Drug: serum antiscorpion
  • Experimental: II
    Patients 15 to 60 years, will receive other commercial serum (Alacramyn)
    Intervention: Drug: serum antiscorpion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
November 2008
October 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Sting scorpion
  • Informed consent
  • Age 15-60
  • Either sex
  • Resident in study area

Exclusion Criteria:

  • Previous treatment with gammaglobulin
  • Blood transfusion at any stage of life
  • Sensitivity or intolerance to serums antiscorpion or horse products
  • Pregnancy
  • Some immunodeficiency
Both
15 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00739440
Birmex-01-2008
No
Ma. Eugenia Jiménez Corona, BIRMEX
Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.
Not Provided
Principal Investigator: Jimenez C Ma. Eugenia, PhD Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.
Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP