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POPULAR (Preference Of Patient Using Levocetirizine in Allergic Rhinitis)

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ClinicalTrials.gov Identifier: NCT00160537
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : December 16, 2013
Sponsor:
Information provided by:
UCB Pharma

Study Description
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Brief Summary:
Comparative study on clinical efficacy and safety of levocetirizine and desloratadine as measured by the subject's satisfaction/dissatisfaction after one week of treatment

Condition or disease Intervention/treatment Phase
Seasonal Allergic Rhinitis Drug: Levocetirizine Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Official Title: A Monocenter, Double-blind, Randomized Trial, With Two Parallel Groups Comparing the Clinical Efficacy of Levocetirizine 5 mg Capsules and Desloratadine 5 mg Capsules Taken Once a Day Over 3 Weeks of Treatment in Adult Subjects Suffering From Seasonal Allergic Rhinitis (SAR) Due to Grass Pollen
Study Start Date : May 2005
Actual Primary Completion Date : July 2005
Actual Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hay Fever
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Subjects' satisfaction / dissatisfaction after the first week of treatment.

Secondary Outcome Measures :
  1. allergic rhinitis symptoms scores over the first week of treatment , subject's satisfaction / dissatisfaction of their choice of treatment after the first week of treatment, time to first feeling of (sufficient) symptom improvement during the first we

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Clinical history of SAR known and treated since 2 years.
  • Positive skin prick test (wheal > 3 mm larger than the diluent control) or RAST (≥3.5 IU/ml) to grass pollen (less than 1 year).
  • Minimum mean T5SS of 8 during the baseline period.

Exclusion Criteria:

  • Have an associated asthma requiring a daily treatment other than β2 short acting agonist prn
  • Have atopic dermatitis or urticaria requiring antihistamine treatment or the administration of oral or topical corticosteroids and any other disease requiring the administration of oral or topical corticosteroids
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00160537


Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center UCB Pharma
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Clinical Study Summary on UCB.com  This link exits the ClinicalTrials.gov site

ClinicalTrials.gov Identifier: NCT00160537     History of Changes
Other Study ID Numbers: A00391
EudraCT 2004-002971-18
POPULAR
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: December 16, 2013
Last Verified: September 2009

Keywords provided by UCB Pharma:
Seasonal Allergic Rhinitis (SAR), Grass pollen, SAR Symptoms (sneezing, rhinorrhea, nasal / ocular pruritus, nasal congestion)
POPULAR, Xyzal, Levocetirizine

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
 Levocetirizine
Cetirizine
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents