Evaluation of Treatment Satisfaction in Children With an... | NCT00453583

Studies
Evaluation of Treatment Satisfaction in Children With an Allergy and Who Received an Antihistamine

NCT00453583

Sponsor

UCB Pharma

Status

Completed

Last Update Posted

Dec 16, 2013Estimated

Enrollment

4,581Actual

Phase

Not provided

Conditions

Allergies

Interventions

Not provided

Countries

United States

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

May 2012

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

Mar 2007

Primary Completion Date

Jan 2008Actual

Completion Date

Jan 2008Actual

First Submitted Date

Mar 28, 2007

First Submission Date that Met QC Criteria

Mar 28, 2007

First Posted Date

Mar 29, 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

Description Module

Brief Summary

This is a non-interventional retrospective data collection study from children aged from 2 to 12 years old diagnosed with an allergy and who received a treatment consisting of an H1-antihistamine. The period of last taken medication will be observed to evaluate the global satisfaction of the parents and physician for this last treatment.

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

4,581Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Parent satisfaction on a 11-point scale		duration of the study

Secondary Outcomes

Measure	Description	Time Frame
Physician satisfaction on an 11-point scale		duration of the study
Efficacy, tolerability and global satisfaction		duration of the study

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children from 2-12 included
History of allergy
Used an Antihistamine within market authorization

Exclusion Criteria:

Child not yet treated for the presented allergy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Primary Care

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
UCB Clinical Trial Call Center	+1 877 822 9493 (UCB)	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UCB Pharma		Smyrna	Georgia		United States