Evaluation of Efficacy and Safety of Levocetirizine to Su... | NCT00521131

Studies
Evaluation of Efficacy and Safety of Levocetirizine to Subjects With Perennial Allergic Rhinitis to House Dust Mites

NCT00521131

Sponsor

UCB Pharma

Status

Completed

Last Update Posted

Dec 16, 2013Estimated

Enrollment

453Actual

Phase

Phase 4

Conditions

Rhinitis
Allergic
Perennial

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

May 2003Actual

Completion Date

May 2003Actual

First Submitted Date

Aug 24, 2007

First Submission Date that Met QC Criteria

Aug 24, 2007

First Posted Date

Aug 27, 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 13, 2013

Last Update Posted Date

Dec 16, 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

Evaluation of Efficacy and Safety of Levocetirizine to Subjects With Perennial Allergic Rhinitis 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

453Actual

Name	Type	Description	Arm Group Labels	Other Names
Levocetirizine dihydrochloride	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of comfortable days, as assessed by the subject		30 days

Secondary Outcomes

Measure	Description	Time Frame
Sum of 4 and 5 rhinitis symptoms and safety		Week 1 and over 30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

male or female ≥ 12 years
suffering from a perennial allergic rhinitis to house dust mites for at least 2 years
positive skin test or positive Radio-Allergo-Sorbent-Test for house dust mites
the mean of the T4SS evaluated in the evening over the last 24 hours of the selection period was ≥ 5

Exclusion Criteria:

seasonal allergic rhinitis likely to change significantly the symptoms of the subject
an ear, nose or throat (ENT) infection during the two weeks preceding initial visit
asthma requiring corticosteroid treatment
atopic dermatitis or urticaria requiring an antihistamine treatment or the administration of oral or topical corticosteroids
associated ENT disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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
D012220	Rhinitis

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
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