NCT00542607

Brief Summary

No information was yet available over the effect of levocetirizine in children under 12 years. The aim of this double-blind, placebo-controlled study was to assess the efficacy and safety of levocetirizine in children from 6 to 12 years old with perennial allergic rhinitis due to house dust mites.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
94

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2002

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

September 1, 2002

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2002

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

October 10, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 11, 2007

Completed
Last Updated

December 12, 2013

Status Verified

September 1, 2009

Enrollment Period

3 months

First QC Date

October 10, 2007

Last Update Submit

December 11, 2013

Conditions

Rhinitis, Allergic, Seasonal

Keywords

Levocetirizine dihydrochlorideXyzal tablets

Outcome Measures

Primary Outcomes (1)

  • Change from baseline of the mean Major symptom complex score over the last 2 hours of a 24-hour coverage

Secondary Outcomes (2)

  • The change from baseline of the mean MSC score over time interval 3

  • the change from baseline of the mean MSC score over time intervals 1 and 4.

Interventions

levocetirizine dihydrochlorideDRUG

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • adults 18 to 55 years both inclusive
  • suffering at least 2 years of seasonal allergic rhinitis due to grass pollen
  • positive RAST and/or positive skin prick test
  • comply with study restrictions

You may not qualify if:

  • known alcohol or drug addiction or abuse
  • known allergy/intolerance to lactose, cellulose, cornstarch
  • presence of nasal anatomical deformities leading to \> 50% obstruction
  • ENT infection within 30 days of the study
  • use of disallowed medication
  • ongoing desensitization
  • known cardiac, renal or hepatic dysfunction
  • presenting allergic bronchial asthma
  • use of cimetidine
  • intending to donate blood during the trial

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 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 10, 2007

First Posted

October 11, 2007

Study Start

September 1, 2002

Primary Completion

December 1, 2002

Study Completion

December 1, 2002

Last Updated

December 12, 2013

Record last verified: 2009-09