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

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.

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00524836
Enrollment
71
Registered
2007-09-05
Start date
2003-09-30
Completion date
2004-02-29
Last updated
2013-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic, Perennial, Rhinitis

Keywords

levocetirizine dihydrochloride, Xyzal tablets

Brief summary

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

Interventions

Sponsors

UCB Pharma
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Total 5 Symptom Score (T5SS) rated by the investigator2 weeks

Secondary

MeasureTime frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026