LEADER (LEvocetirizine And DEsloratadine in Allergic Rhin... | NCT00160589

Studies
LEADER (LEvocetirizine And DEsloratadine in Allergic Rhinitis)

NCT00160589

Sponsor

UCB Pharma

Status

Completed

Last Update Posted

Dec 16, 2013Estimated

Enrollment

729

Phase

Phase 4

Conditions

Rhinitis, Allergic, Perennial

Interventions

Levocetirizine

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

Official Title

A Multicentre, Double-blind, Parallel, Randomized, Placebo-controlled Study : Evaluation of the Efficacy and Safety of Levocetirizine 5 mg and Desloratadine 5 mg Administered Orally as Capsules Once Daily, in the Morning, Over 2 Weeks in Patients Suffering From Allergic Rhinitis (AR)

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

Apr 2005

Primary Completion Date

Sep 2005Actual

Completion Date

Sep 2005Actual

First Submitted Date

Sep 8, 2005

First Submission Date that Met QC Criteria

Sep 8, 2005

First Posted Date

Sep 12, 2005Estimated

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

Description Module

Brief Summary

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

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

729

Name	Type	Description	Arm Group Labels	Other Names
Levocetirizine	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean change from baseline of T4SS (four symptoms score) over two weeks of treatment

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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,

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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
D012221	Rhinitis, Allergic, Perennial
D012912	Sneezing
D000086722	Rhinorrhea
D015508	Nasal Obstruction

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