A Worldwide Antihistamine-Refractory Chronic Urticaria Patient Evaluation in Latin America and Canada (AWARE-LACan)
NCT ID: NCT02626221
Last Updated: 2018-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
497 participants
OBSERVATIONAL
2014-12-24
2018-03-21
Brief Summary
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In accordance with the observational nature of the study, there will be no interventions or interference with the routine care of the patient which will be based solely on the clinical judgment of the treating physician. However, with respect to the frequency and schedule of assessments, the schedule included in Table 7-1 will be recommended.
The selection of the treatment for CU will be clearly separated from the decision to include the patient in the study, and will be made at the discretion of the treating physician in accordance with standard medical practice, the investigator's clinical judgment, and global urticarial guidelines.
In order to prevent selection bias, investigators should offer enrollment to all consecutive patients meeting study criteria, likely to be available for the full duration of the follow-up period of 24 months, and willing to participate in the study.
The overall objective of the study is to evaluate in real-life the CU disease burden, the current treatment patterns and the use of health care resources in patients refractory to H1-antihistamine treatment
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Single
Single Cohort Study
Non Interventional Study
Non Interventional Study
Interventions
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Non Interventional Study
Non Interventional Study
Eligibility Criteria
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Inclusion Criteria
Patient has been treated with at least one course of H1 antihistamines and is refractory to this treatment Patient has provided written informed consent allowing the use of their anonymous data for the purposes of the study
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Novartis Investigative Site
CABA, Buenos Aires, Argentina
Novartis Investigative Site
Ciudad Autonoma de Bs As, Buenos Aires, Argentina
Novartis Investigative Site
Ciudad Autonoma de Bs As, Buenos Aires, Argentina
Novartis Investigative Site
Lobos, Buenos Aires, Argentina
Novartis Investigative Site
Buenos Aires, Nueve De Julio, Argentina
Novartis Investigative Site
Rosario, Santa Fe Province, Argentina
Novartis Investigative Site
Rosario, Santa Fe Province, Argentina
Novartis Investigative Site
Buenos Aires, , Argentina
Novartis Investigative Site
Mendoza, , Argentina
Novartis Investigative Site
Salta, , Argentina
Novartis Investigative Site
Rio de Janeiro, Rio de Janeiro, Brazil
Novartis Investigative Site
Alphaville / Barueri, São Paulo, Brazil
Novartis Investigative Site
Guarulhos, São Paulo, Brazil
Novartis Investigative Site
Santo André, São Paulo, Brazil
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Novartis Investigative Site
Medellín, Antioquia, Colombia
Novartis Investigative Site
Barranquilla, Atlántico, Colombia
Novartis Investigative Site
Bogotá, Cundinamarca, Colombia
Novartis Investigative Site
Medellín, , Colombia
Novartis Investigative Site
San José, , Costa Rica
Novartis Investigative Site
San Rafael Escazu, , Costa Rica
Novartis Investigative Site
Santiago de los Caballeros, Republica Dominicana, Dominican Republic
Novartis Investigative Site
Santo Domingo, Republica Dominicana, Dominican Republic
Novartis Investigative Site
Santo Domingo, , Dominican Republic
Novartis Investigative Site
Guatemala City, , Guatemala
Novartis Investigative Site
San Pedro Sula, , Honduras
Novartis Investigative Site
San Pedro Sula, , Honduras
Novartis Investigative Site
Tegucigalpa, , Honduras
Novartis Investigative Site
Panama City, , Panama
Novartis Investigative Site
Jesus Maria, Lima region, Peru
Novartis Investigative Site
San Martín de Porres, Lima region, Peru
Countries
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Other Identifiers
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CIGE025EVE01
Identifier Type: -
Identifier Source: org_study_id