To Evaluate the Efficacy and Safety of Levocetirizine Versus Loratadine for Treatment of Seasonal Allergic Rhinitis
Information source: UCB
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rhinitis; Allergic; Seasonal
Intervention: Levocetirizine dihydrochloride (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: UCB Official(s) and/or principal investigator(s):
Isabelle Campine, Study Director, Affiliation: UCB
Summary
To Evaluate the Efficacy and Safety of Levocetirizine Versus Loratadine for Treatment of
Seasonal Allergic Rhinitis
Clinical Details
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)
Study design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment
Primary outcome: Investigator rated T5SS (Total 5 symptom Score) over 2 weeks
Secondary outcome: 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).
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: August 2003
Ending date: October 2003
Last updated: March 6, 2008
|
