NCT00723736

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2007

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 29, 2008

Completed
1 year until next milestone

Results Posted

Study results publicly available

August 6, 2009

Completed
Last Updated

February 9, 2022

Status Verified

February 1, 2022

Enrollment Period

6 months

First QC Date

July 25, 2008

Results QC Date

June 18, 2009

Last Update Submit

February 7, 2022

Conditions

RhinitisUrticaria

Outcome Measures

Primary Outcomes (1)

  • Proportion of Patients With Adverse Events

    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.

    Follow-up visit at 3 - 5 weeks after treatment initiation

Study Arms (1)

Pediatric Patients

Those with allergic rhinitis or chronic idiopathic urticaria.

Drug: Desloratadine

Interventions

DesloratadineDRUG

2.5 ml (1.25 mg) once daily

Also known as: Aerius, SCH 034117
Pediatric Patients

Eligibility Criteria

Age1 Year - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Pediatric clinics around Hungary.

You may qualify if:

  • Patients with allergic rhinitis or chronic idiopathic urticaria
  • Aged 1-5 years old
  • Caregiver's consent to participate

You may not qualify if:

  • Healthy individuals
  • Younger or older than the 1-5 year old age range

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

RhinitisUrticaria

Interventions

desloratadine

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck, Sharp & Dohme Corp.
ClinicalTrialsDisclosure@merck.com

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2008

First Posted

July 29, 2008

Study Start

December 1, 2007

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

February 9, 2022

Results First Posted

August 6, 2009

Record last verified: 2022-02