NCT00624078|CompletedPhase 2/3
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Sponsor study identifier
interventional
1,426
1 country
18
Study Start
May 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2010
Actual (reported)Study Completion
September 2010
Actual (reported)This treatment protocol will enable therapeutic use of Anascorp in the management of systemic manifestations of scorpion sting envenomation, in patients for whom antivenom would otherwise be unavailable. The working hypotheses are as follows:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2005
Date type not reportedThis date has not been verified as actual or estimated.
December 26, 2007
Actual (reported)February 26, 2008
Actual (reported)September 2010
Actual (reported)September 2010
Actual (reported)Evaluate the adverse events profile of each patient
immediately after treatment, 24 hrs and 14 days.
Resolution of systemic signs of scorpion envenomation
after treatment
Patients who arrive to emergency room with scorpion sting envenomation will be evaluated according to inclusion/exclusion criteria. After informed consent has been signed they will be assigned to unique treatment arm with Anascorp.
three vials diluted in 20 to 50 mL normal saline administered intravenously. Subsequent single vial doses of Anascorp, up to a total of five vials administered at thirty minutes intervals until resolution of symptoms.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Casa Grande Regional Medical Center
Casa Grande, Arizona, 85222, United States
Chandler Regional
Chandler, Arizona, 85224, United States
Southeast Arizona Medical Center
Douglas, Arizona, 85260, United States
Mercy Gilbert Medical Center
Gilbert, Arizona, 85297, United States
Banner Thunderbird Medical Center
Glendale, Arizona, 85306, United States
Banner Baywood Medical Center
Mesa, Arizona, 86206, United States
Gila Health Resources
Morenci, Arizona, 85540, United States
Vazquez H, Chavez-Haro A, Garcia-Ubbelohde W, Mancilla-Nava R, Paniagua-Solis J, Alagon A, Sevcik C. Pharmacokinetics of a F(ab')2 scorpion antivenom in healthy human volunteers. Toxicon. 2005 Dec 1;46(7):797-805. doi: 10.1016/j.toxicon.2005.08.010. Epub 2005 Sep 28.
Likes K, Banner W Jr, Chavez M. Centruroides exilicauda envenomation in Arizona. West J Med. 1984 Nov;141(5):634-7.
Lai MW, Klein-Schwartz W, Rodgers GC, Abrams JY, Haber DA, Bronstein AC, Wruk KM. 2005 Annual Report of the American Association of Poison Control Centers' national poisoning and exposure database. Clin Toxicol (Phila). 2006;44(6-7):803-932. doi: 10.1080/15563650600907165.
Leslie Boyer, M.D
VIPER Institute
Walter Garcia, M.D
Instituto Bioclon S.A. de C.V.
1,426 participants (actual enrollment reported by the registry).
First Submitted
December 26, 2007
First Posted
February 26, 2008
Study Start
May 2005
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Holy Cross Hospital
Nogales, Arizona, 85621, United States
Maricopa Medical Center
Phoenix, Arizona, 85008, United States
Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
John C. Lincoln
Phoenix, Arizona, 85027, United States
Mt. Graham Regional Medical Center
Safford, Arizona, 85546, United States
San Carlos Indian Hospital
San Carlos, Arizona, 85550, United States
Scottsdale Healthcare
Scottsdale, Arizona, 85260, United States
Tucson Medical Center
Tucson, Arizona, 85712, United States
University Medical Center
Tucson, Arizona, 85724, United States
St. Mary's Hospital
Tucson, Arizona, 85745, United States
Whiteriver IHS Hospital
Whiteriver, Arizona, 85941, United States
Gibly R, Williams M, Walter FG, McNally J, Conroy C, Berg RA. Continuous intravenous midazolam infusion for Centruroides exilicauda scorpion envenomation. Ann Emerg Med. 1999 Nov;34(5):620-5. doi: 10.1016/s0196-0644(99)70164-2.
Riley BD, LoVecchio F, Pizon AF. Lack of scorpion antivenom leads to increased pediatric ICU admissions. Ann Emerg Med. 2006 Apr;47(4):398-9. doi: 10.1016/j.annemergmed.2005.11.042. No abstract available.
Primary Completion
September 2010
Actual (reported)Study Completion
September 2010
Actual (reported)Last Updated
February 23, 2011
Record last verified: 2011-02
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Source: ClinicalTrials.gov.
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