LEADER (LEvocetirizine And DEsloratadine in Allergic Rhinitis)

December 13, 2013 updated by: UCB Pharma

A Multicentre, Double-blind, Parallel, Randomized, Placebo-controlled Study : Evaluation of the Efficacy and Safety of Levocetirizine 5 mg and Desloratadine 5 mg Administered Orally as Capsules Once Daily, in the Morning, Over 2 Weeks in Patients Suffering From Allergic Rhinitis (AR)

Two weeks study to evaluate the efficacy and safety of Levocetirizine and Desloratadine in patients suffering from Allergic Rhinitis (AR)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

729

Phase

  • Phase 4

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • At least 2-year history of Allergic Rhinitis that became symptomatic during the annual grass pollen season.
  • A skin test for grass pollens positive:
  • Have rhinitis symptoms of such severity that the mean T4SS over the baseline period must be 6.

Exclusion Criteria:

  • Have an associated asthma requiring corticosteroid treatment,
  • Have an atopic dermatitis or an urticaria requiring an antihistamine treatment or the administration of oral or topical corticosteroids,

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Mean change from baseline of T4SS (four symptoms score) over two weeks of treatment

Secondary Outcome Measures

Outcome Measure
Clinical efficacy over the first and over two weeks of treatment measured by symptoms (scored and individuals); Onset of action; Safety

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

April 1, 2005

Primary Completion (Actual)

September 1, 2005

Study Completion (Actual)

September 1, 2005

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (Estimate)

September 12, 2005

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

  • A00401
  • LEADER
  • EudraCT2004-002823-42

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.

Clinical Trials on Rhinitis, Allergic, Perennial

Clinical Trials on Levocetirizine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe