Randomized Controlled Trial to Compare Two Anti-scorpion... | NCT00739440

Studies
Randomized Controlled Trial to Compare Two Anti-scorpion Serums

NCT00739440

Sponsor

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

Status

Completed

Last Update Posted

Aug 7, 2013Estimated

Enrollment

120Actual

Phase

Phase 4

Conditions

Scorpion Sting

Interventions

serum antiscorpion

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

Oct 2008Actual

Completion Date

Nov 2008Actual

First Submitted Date

Aug 19, 2008

First Submission Date that Met QC Criteria

Aug 20, 2008

First Posted Date

Aug 21, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 6, 2013

Last Update Posted Date

Aug 7, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
serum antiscorpion	Biological	The dose may be required for the patient according to clinical manifestations and evolution	I II

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Resolution of signs and symptoms of scorpion envenomation		after treatment (expected average of 12 hrs)

Secondary Outcomes

Measure	Description	Time Frame
Evaluate the adverse events in every treated child		inmediately after treatment and until 5 days later

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jimenez C Ma. Eugenia, PhD	Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D065008	Scorpion Stings

Ancestor Terms

ID	Term
D001733	Bites and Stings
D011041	Poisoning
D064419	Chemically-Induced Disorders
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided