Evaluation of Safety of Levocetirizine in Routine Clinical Practice-non- Interventional Study

NCT ID: NCT00598780

Last Updated: 2012-05-28

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

7870 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-09-30

Brief Summary

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To evaluate over a period of 6 months the safety and the treatment satisfaction of newly prescribed levocetirizine in patients of age ≥ 2 years with persistent allergic rhinitis.

Detailed Description

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This is a non-interventional, prospective, post-authorization, multi-centre cohort study in patients treated with levocetirizine.

The baseline data will be collected at the visit to the physician when levocetirizine is prescribed for the first time for the patient for Persistent Allergic Rhinitis. The data will then be collected during 2 visits occurring within the first 6 months of treatment, as usually scheduled in normal clinical practice in the Czech and Slovak Republics. This is after approximately 4 weeks and 6 months of treatment or earlier, if the treatment is stopped

Conditions

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Rhinitis Allergic, Persistent

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Patients with newly diagnosed persistent allergic rhinitis, within the approved age limits.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* diagnosis of persistent allergic rhinitis
* first prescription of levocetirizine for this diagnosis for this patient
* age ≥ 2 years

* history of allergic or anaphylactic reactions to levocetirizine or other derivatives and excipients included
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UCB Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

+1 877 822 9493 (UCB)

Locations

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UCB Pharma

Smyrna, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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A00421

Identifier Type: -

Identifier Source: org_study_id

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