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

December 13, 2013 updated by: UCB Pharma

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Investigator rated T5SS (Total 5 symptom Score) over 2 weeks
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2003

Primary Completion (ACTUAL)

October 1, 2003

Study Completion (ACTUAL)

October 1, 2003

Study Registration Dates

First Submitted

September 4, 2007

First Submitted That Met QC Criteria

September 4, 2007

First Posted (ESTIMATE)

September 5, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

December 16, 2013

Last Update Submitted That Met QC Criteria

December 13, 2013

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A00348

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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