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Double-Blind, Alacramyn® vs. Placebo in Pediatric Patients

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ClinicalTrials.gov Identifier: NCT00685230
Recruitment Status : Completed
First Posted : May 28, 2008
Last Update Posted : June 2, 2011
Sponsor:
Collaborators:
University of Arizona
Universidad Nacional Autonoma de Mexico
Information provided by:
Instituto Bioclon S.A. de C.V.

Results Submitted - Not Posted on ClinicalTrials.gov
Results information has been submitted to ClinicalTrials.gov by the sponsor or investigator, but is not yet publicly available (or "posted") on ClinicalTrials.gov. The submitted information may not be available if it is pending Quality Control (QC) Review by the National Library of Medicine (NLM) or if issues identified during QC review are being addressed or corrected by the sponsor or investigator. NLM's limited QC review assesses for apparent errors, deficiencies, or inconsistencies. NLM staff do not verify the scientific validity or relevance of the submitted information.
  Recruitment Status : Completed
  Actual Primary Completion Date : August 2005
  Actual Study Completion Date : October 2005

Submission Cycle Results Submitted to ClinicalTrials.gov Results Returned after Quality Control Review
1 June 10, 2011
July 12, 2011
2 January 9, 2012
February 8, 2012
3 November 19, 2015
December 22, 2015
4 January 18, 2016
February 12, 2016
5 March 18, 2016
April 19, 2016
Publications:
Connor, D.A., Seldon, B.S., Scorpion Envenomation. Chapter in Wilderness Medicine; Management of Wilderness and Environmental Emergencies. 3rd edition. Auerbach PS, ed., Mosby Yearbook, Inc. St. Louis, MO. pp 831-842
Chavez-Haro A., Gonzalez J., Paniagua nJ., Efficiency and Security Comparison between Two Different Scorpion-derived Antivenom in Mexico, Abstract, Leon Study Data Analysis.
Gonzalez, C., et al, Development of an Immunoenzymatic Assay for the Quantification of Scorpion Venom in Plasma, Abstract, Cuernavaca, 2000
Alagon Cano, A., Gozalez Juarez, C., From Serotherapy to Fabotherapy, Abstract, Cuernavaca, 1998.
Cabral-Soto, J., et al, Comparison of Efficacy between Two Antiscorpion Antivenoms, Abstract, Cuernavaca, 2000, Clinical Study Report, Randomized, Double-Blind, Variable dosing of Alacramyn in Patients With Scorpion Sting (this was done with two approved products in Mexico, Alacramyn and Birmex), March 2002.
Madrazo Navarro, M., et al, Animales Ponzoñosos en la Población Derechohabiente del IMSS 1990-1996.
Dart, R.C., Horowitz, R.S., Use of Antibodies as Antivenoms: A primitive Solution for Complex Problem? Rocky Mountain Poison and Drug Center, Denver Co, USA.
TESS Data Collection Manual (available upon request)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):