Back to resultsTo Evaluate the Efficacy and Safety of Levocetirizine Versus Loratadine for Treatment of Seasonal Allergic Rhinitis
Primary Purpose
Rhinitis, Allergic, Seasonal
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Levocetirizine dihydrochloride
Sponsored by
About this trial
This is an interventional treatment trial for Rhinitis focused on measuring Levocetirizine dihydrochloride, Xyzal tablets
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
Investigator rated T5SS (Total 5 symptom Score) over 2 weeks
Secondary Outcome 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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00525278
Brief Title
To Evaluate the Efficacy and Safety of Levocetirizine Versus Loratadine for Treatment of Seasonal Allergic Rhinitis
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 Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
October 2003 (Actual)
Study Completion Date
October 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
UCB Pharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To Evaluate the Efficacy and Safety of Levocetirizine Versus Loratadine for Treatment of Seasonal Allergic Rhinitis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis, Allergic, Seasonal
Keywords
Levocetirizine dihydrochloride, Xyzal tablets
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Levocetirizine dihydrochloride
Primary Outcome Measure Information:
Title
Investigator rated T5SS (Total 5 symptom Score) over 2 weeks
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
UCB Pharma
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
To Evaluate the Efficacy and Safety of Levocetirizine Versus Loratadine for Treatment of Seasonal Allergic Rhinitis
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