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Efficacy and Safety of Levocetirizine and Fexofenadine in Reducing Symptoms of Seasonal Allergic Rhinitis

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ClinicalTrials.gov Identifier: NCT00542607
Recruitment Status : Completed
First Posted : October 11, 2007
Last Update Posted : December 12, 2013
Sponsor:
Information provided by:
UCB Pharma

Brief Summary:
No information was yet available over the effect of levocetirizine in children under 12 years. The aim of this double-blind, placebo-controlled study was to assess the efficacy and safety of levocetirizine in children from 6 to 12 years old with perennial allergic rhinitis due to house dust mites.

Condition or disease Intervention/treatment Phase
Rhinitis, Allergic, Seasonal Drug: levocetirizine dihydrochloride Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Trial to Compare the Efficacy and Safety of Levocetirizine 5 mg od and Fexofenadine 120 mg od in Reducing Symptoms of Seasonal Allergic Rhinitis in Grass Pollen Sensitized Adults
Study Start Date : September 2002
Actual Primary Completion Date : December 2002
Actual Study Completion Date : December 2002

Resource links provided by the National Library of Medicine

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




Primary Outcome Measures :
  1. Change from baseline of the mean Major symptom complex score over the last 2 hours of a 24-hour coverage

Secondary Outcome Measures :
  1. The change from baseline of the mean MSC score over time interval 3
  2. the change from baseline of the mean MSC score over time intervals 1 and 4.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adults 18 to 55 years both inclusive
  • suffering at least 2 years of seasonal allergic rhinitis due to grass pollen
  • positive RAST and/or positive skin prick test
  • comply with study restrictions

Exclusion Criteria:

  • known alcohol or drug addiction or abuse
  • known allergy/intolerance to lactose, cellulose, cornstarch
  • presence of nasal anatomical deformities leading to > 50% obstruction
  • ENT infection within 30 days of the study
  • use of disallowed medication
  • ongoing desensitization
  • known cardiac, renal or hepatic dysfunction
  • presenting allergic bronchial asthma
  • use of cimetidine
  • intending to donate blood during the trial

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): NCT00542607


Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCb Clinical Trial Call Center UCB Pharma

Additional Information:
ClinicalTrials.gov Identifier: NCT00542607     History of Changes
Other Study ID Numbers: A00324
First Posted: October 11, 2007    Key Record Dates
Last Update Posted: December 12, 2013
Last Verified: September 2009

Keywords provided by UCB Pharma:
Levocetirizine dihydrochloride
Xyzal tablets

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
Fexofenadine
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