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Trial record 1 of 1 for:    NCT00453583
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Evaluation of Treatment Satisfaction in Children With an Allergy and Who Received an Antihistamine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00453583
Recruitment Status : Completed
First Posted : March 29, 2007
Last Update Posted : December 16, 2013
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Tracking Information
First Submitted Date March 28, 2007
First Posted Date March 29, 2007
Last Update Posted Date December 16, 2013
Study Start Date March 2007
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 27, 2008)
Parent satisfaction on a 11-point scale [ Time Frame: duration of the study ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: January 27, 2008)
  • Physician satisfaction on an 11-point scale [ Time Frame: duration of the study ]
  • Efficacy, tolerability and global satisfaction [ Time Frame: duration of the study ]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of Treatment Satisfaction in Children With an Allergy and Who Received an Antihistamine
Official Title Evaluation of the Treatment Satisfaction in Children Suffering From an Allergy and Who Received an Antihistamine Treatment
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
Study Type Observational
Study Design Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Primary Care
Condition Allergies
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 11, 2009)
4581
Original Enrollment
 (submitted: March 28, 2007)
5000
Actual Study Completion Date January 2008
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 2 Years to 12 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries Bulgaria,   India,   Korea, Republic of,   Portugal,   Romania,   Russian Federation,   Spain
 
Administrative Information
NCT Number NCT00453583
Other Study ID Numbers A00420
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party UCB Pharma
Study Sponsor UCB Pharma
Collaborators Not Provided
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
PRS Account UCB Pharma
Verification Date May 2012