NCT00739440

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2008

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

August 19, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

August 7, 2013

Status Verified

August 1, 2013

Enrollment Period

2 months

First QC Date

August 19, 2008

Last Update Submit

August 6, 2013

Conditions

Scorpion Sting

Outcome Measures

Primary Outcomes (1)

  • Resolution of signs and symptoms of scorpion envenomation

    after treatment (expected average of 12 hrs)

Secondary Outcomes (1)

  • Evaluate the adverse events in every treated child

    inmediately after treatment and until 5 days later

Study Arms (2)

I

EXPERIMENTAL

Patients 15 to 60 years with scorpion sting, will receive serum antiscorpion elaborated by Birmex

Biological: serum antiscorpion

II

EXPERIMENTAL

Patients 15 to 60 years with scorpion sting, will receive other commercial serum antiscorpion (Alacramyn)

Biological: serum antiscorpion

Interventions

serum antiscorpionBIOLOGICAL

The dose may be required for the patient according to clinical manifestations and evolution

Also known as: anti-Scorpion venom Serum
III

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Previous treatment with gammaglobulin
  • Blood transfusion at any stage of life
  • Sensitivity or intolerance to serums antiscorpion or horse products
  • Pregnancy
  • Some immunodeficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Scorpion Stings

Condition Hierarchy (Ancestors)

Bites and StingsPoisoningChemically-Induced DisordersWounds and Injuries

Study Officials

  • Jimenez C Ma. Eugenia, PhD

    Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2008

First Posted

August 21, 2008

Study Start

August 1, 2008

Primary Completion

October 1, 2008

Study Completion

November 1, 2008

Last Updated

August 7, 2013

Record last verified: 2013-08