Skip to main content
OpenTrials
Completed

NCT Number: NCT00525278

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Rhinitis Allergic Infections Nose Diseases Otorhinolaryngologic Diseases Respiratory Tract Diseases Respiratory Tract Infections Seasonal

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

levocetirizine dihydrochloride

Drug

Primary outcomes

  1. Investigator rated T5SS (Total 5 symptom Score) over 2 weeks

    Time frame: 2 weeks

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study 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)

Important dates

Study start
2003
Primary completion
2003
Study completion
2003
First posted
Sep 5, 2007
Registry last updated
Dec 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.