NCT00160589

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
729

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2005

Shorter than P25 for phase_4

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, 2005

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

December 16, 2013

Status Verified

September 1, 2009

Enrollment Period

5 months

First QC Date

September 8, 2005

Last Update Submit

December 13, 2013

Conditions

Rhinitis, Allergic, Perennial

Keywords

Allergic Rhinits, Symptoms (sneezing, rhinorrhea, nasal/ocular pruritus, nasal congestion), LEADER, Xyzal, Levocetirizine

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

LevocetirizineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rhinitis, Allergic, PerennialSneezingRhinorrheaNasal Obstruction

Interventions

levocetirizine

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsAirway ObstructionRespiratory InsufficiencyRespiration Disorders

Study Officials

  • UCB Clinical Trial Call Center

    UCB Pharma

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

April 1, 2005

Primary Completion

September 1, 2005

Study Completion

September 1, 2005

Last Updated

December 16, 2013

Record last verified: 2009-09