NCT00544388

Brief Summary

Controlled conditions of the EEU allow a reliable assessment of the efficacy and a determination of the action onset, action intensity and duration of effect of levocetirizine and cetirizine in order to establish the relative efficacy of these two drugs available for the treatment of SAR.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
570

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Apr 2004

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2004

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

October 15, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 16, 2007

Completed
Last Updated

December 16, 2013

Status Verified

September 1, 2009

Enrollment Period

3 months

First QC Date

October 15, 2007

Last Update Submit

December 13, 2013

Conditions

Rhinitis, Allergic, Seasonal

Keywords

Levocetirizine dihydrochlorideXyzal tablet

Outcome Measures

Primary Outcomes (1)

  • Mean change from baseline in major symptom complex score over Period 2 (21-29 hours after drug intake on Day 2).

Secondary Outcomes (1)

  • Mean change from baseline in MSC score over each 2-hour interval.

Interventions

levocetirizine dihydrochlorideDRUG

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Male/Female, aged \>= 16 years
  • seasonal allergic rhinitis that required pharmacologic therapy each year during the last 2 ragweed pollen seasons
  • documented seasonal allergy to ragweed pollen
  • total symptom score of at least 18 points.

You may not qualify if:

  • nasal anatomic deformities ? 50% obstruction
  • acute sinusitis within 30 days of Period 2
  • initiated or advanced an immunotherapy regimen
  • immunotherapy injections within 48 hours of pollen exposure
  • impaired hepatic function
  • history of malignancy
  • intolerance to histamines
  • asthma requiring medication more than occasionally

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

levocetirizine

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • UCB Clinical Trial Call Center

    UCB Pharma

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 15, 2007

First Posted

October 16, 2007

Study Start

April 1, 2004

Primary Completion

July 1, 2004

Study Completion

July 1, 2004

Last Updated

December 16, 2013

Record last verified: 2009-09