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NCT00525278 Clinical Trial

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

Rhinitis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00525278
Other study ID # A00348
Secondary ID
Status Completed
Phase Phase 3
First received September 4, 2007
Last updated December 13, 2013
Start date August 2003
Est. completion date October 2003

Study information
Verified date September 2009
Source UCB Pharma
Contact n/a
Is FDA regulated No
Health authority China: Department of Health, Pharmaceuticals registration and Import/Export control section
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 67
Est. completion date October 2003
Est. primary completion date October 2003
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Levocetirizine dihydrochloride

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
UCB Pharma

Outcome
Type Measure Description Time frame Safety issue
Primary Investigator rated T5SS (Total 5 symptom Score) over 2 weeks 2 weeks
Secondary 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). 2 weeks
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