Efficacy and Safety of Levocetirizine and Fexofenadine in... | NCT00542607

Studies
Efficacy and Safety of Levocetirizine and Fexofenadine in Reducing Symptoms of Seasonal Allergic Rhinitis

NCT00542607

Sponsor

UCB Pharma

Status

Completed

Last Update Posted

Dec 12, 2013Estimated

Enrollment

94Actual

Phase

Phase 4

Conditions

Rhinitis, Allergic, Seasonal

Interventions

levocetirizine dihydrochloride

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2002

Primary Completion Date

Dec 2002Actual

Completion Date

Dec 2002Actual

First Submitted Date

Oct 10, 2007

First Submission Date that Met QC Criteria

Oct 10, 2007

First Posted Date

Oct 11, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 11, 2013

Last Update Posted Date

Dec 12, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

94Actual

Name	Type	Description	Arm Group Labels	Other Names
levocetirizine dihydrochloride	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline of the mean Major symptom complex score over the last 2 hours of a 24-hour coverage

Secondary Outcomes

Measure	Description	Time Frame
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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
UCb Clinical Trial Call Center	UCB Pharma	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D006255	Rhinitis, Allergic, Seasonal

Ancestor Terms

ID	Term
D065631	Rhinitis, Allergic
D012220	Rhinitis
D009668	Nose Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C472067	levocetirizine

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided