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NCT00524836 Clinical Trial

Efficacy and Safety of Levocetirizine Versus Loratadine for the Treatment of Perennial Allergic Rhinitis

Rhinitis Clinical Trial

Official title:
A 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 Perennial Allergic Rhinitis.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00524836
Other study ID # A00349
Secondary ID
Status Completed
Phase Phase 3
First received September 4, 2007
Last updated December 13, 2013
Start date September 2003
Est. completion date February 2004

Study information
Verified date September 2009
Source UCB Pharma
Contact n/a
Is FDA regulated No
Health authority China: Ministry of Health
Study type Interventional

Clinical Trial Summary

Efficacy and Safety of Levocetirizine Versus Loratadine for the Treatment of Perennial Allergic Rhinitis.

Recruitment information / eligibility
Status Completed
Enrollment 71
Est. completion date February 2004
Est. primary completion date February 2004
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Male ore female, 16 to 60 years old (inclusive)

- two-year history of allergic rhinitis due to house dust mite

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

- desensitivation

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 Total 5 Symptom Score (T5SS) rated by the investigator 2 weeks
Secondary Investigators global efficacy evaluation at the end of treatment; subject's rating of T5SS and individual symptoms (over the last 24 hours) over first week and the total 2 weeks treatment period; the Symptoms Score Reducing Index (SSRI). 2 weeks
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