Safety of Aerius Syrup in Pediatric Patients Aged 1-5 Years Old With Allergic Rhinitis or Chronic Idiopathic Urticaria (Study P04446AM1)(COMPLETED)
This study has been completed.
Sponsor:
Schering-Plough
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00723736
First received: July 25, 2008
Last updated: May 27, 2010
Last verified: May 2010
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| Tracking Information | |
|---|---|
| First Received Date ICMJE | July 25, 2008 |
| Last Updated Date | May 27, 2010 |
| Start Date ICMJE | December 2007 |
| Primary Completion Date | June 2008 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
Proportion of Patients With Adverse Events [ Time Frame: Follow-up visit at 3 - 5 weeks after treatment initiation ] [ Designated as safety issue: Yes ] An adverse event is any untoward medical occurrence or unfavorable and unintended sign in a subject administered a pharmaceutical product, whether or not considered related to the use of that product. This includes the onset of new illness and the exacerbation of pre-existing conditions. |
| Original Primary Outcome Measures ICMJE |
Adverse Events [ Time Frame: Follow-up visit a few weeks after treatment initiation ] [ Designated as safety issue: Yes ] |
| Change History | Complete list of historical versions of study NCT00723736 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | Not Provided |
| Original Secondary Outcome Measures ICMJE |
Joint Parent/Child Global Therapeutic Response [ Time Frame: Follow-up visit a few weeks after treatment initiation ] [ Designated as safety issue: No ] |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Safety of Aerius Syrup in Pediatric Patients Aged 1-5 Years Old With Allergic Rhinitis or Chronic Idiopathic Urticaria (Study P04446AM1)(COMPLETED) |
| Official Title ICMJE | Non-Interventional Study of the Safe Use of Aerius in Pediatric Patients With Allergic Rhinitis or Chronic Idiopathic Urticaria. |
| Brief Summary | The objective of this non-interventional study is to evaluate the safety of Aerius syrup in pediatric patients aged 1-5 years old with allergic rhinitis or chronic idiopathic uticaria. The patients will receive 2.5 ml (1.25 mg) once daily. |
| Detailed Description | Pediatric patients aged 1-5 years |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
| Target Follow-Up Duration | Not Provided |
| Biospecimen | Not Provided |
| Sampling Method | Non-Probability Sample |
| Study Population | Pediatric clinics around Hungary. |
| Condition ICMJE |
|
| Intervention ICMJE | Drug: Desloratadine
2.5 ml (1.25 mg) once daily
Other Names:
|
| Study Group/Cohort (s) | Pediatric Patients
Those with allergic rhinitis or chronic idiopathic urticaria.
Intervention: Drug: Desloratadine |
| 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 ICMJE | Completed |
| Enrollment ICMJE | 100 |
| Completion Date | June 2008 |
| Primary Completion Date | June 2008 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
| Gender | Both |
| Ages | 1 Year to 5 Years |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | Not Provided |
| Administrative Information | |
| NCT Number ICMJE | NCT00723736 |
| Other Study ID Numbers ICMJE | P04446 |
| Has Data Monitoring Committee | No |
| Responsible Party | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| Study Sponsor ICMJE | Schering-Plough |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | Schering-Plough |
| Verification Date | May 2010 |
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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