Official Title: “Study Evaluating the Efficacy and Safety of 5 mg Levocetirizine Oral Tablets, Once Daily Versus 10 mg Loratadine Oral Tablets, Once Daily for the Treatment of Seasonal Allergic Rhinitis (SAR)”

To Evaluate the Efficacy and Safety of Levocetirizine Versus Loratadine for Treatment of Seasonal Allergic Rhinitis

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment

Study Primary Completion Date: October 2003

Intervention(s) in this Clinical Trial

• Drug: Levocetirizine dihydrochloride

Primary Measures

• Investigator rated T5SS (Total 5 symptom Score) over 2 weeks
  • Time Frame: 2 weeks
    

Secondary Measures

• Investigator's global efficacy evaluation at 2 weeks; the patient's mean T5SS and 5 individual symptoms (over the last 24 hours) over the first week and over the 2 weeks of treatment; the Symptoms Score Reducing Index (SSRI).
  • Time Frame: 2 weeks
    

Inclusion Criteria:

• Male or female, 18 to 60 years old, inclusive
• two-year history of allergic rhinitis due to tree, grass or weed pollen
• sufficient histamine-dependent symptoms of rhinitis during the selection week (T5SS ≥ 5)

Exclusion Criteria:

• An ear, nose or throat (ENT) infection
• asthma requiring daily drug therapy other than ß2 inhaled agonists taken prn
• atopic dermatitis or urticaria requiring an antihistamine or corticosteroid treatment
• an associated ENT disease
• use of decongestants
• nasal or ocular topical treatment

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: UCB

Overall Clinical Trial Officials and Contacts

Isabelle Campine Study Director UCB  

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00525278

Study ID Number: A00348

ClinicalTrials.gov Identifier: NCT00525278

Health Authority: China: Department of Health, Pharmaceuticals registration and Import/Export control section