Response of Desloratadine Syrup in the Relief of Symptoms Associated With Perennial Allergic Rhinitis in Pediatric Patients (Study P04299)(COMPLETED)

This study has been completed.

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00704769

Purpose

Evaluate the safety and general clinical response of desloratadine syrup in the relief of symptoms associated with perennial allergic rhinitis in Indonesian pediatric patients.

Condition	Intervention
Rhinitis	Drug: Desloratadine

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Observational Study Evaluating the Safety and Efficacy of Desloratadine Syrup for Perennial Allergic Rhinitis in Indonesian Pediatric Patients

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Adverse Events [ Time Frame: Visits 1 & 2 ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	606
Study Start Date:	May 2005
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Children with a history of perennial allergic rhinitis	Drug: Desloratadine Desloratadine syrup, 2.5 mL (1.25mg) once daily for 2-5 year olds, 5 mL (2.5mg) once daily for 6-11 year olds, minimum 7 days of treatment, minimum of 2 visits

Detailed Description:

Children, ages 2-11, with a history of perennial allergic rhinitis

Eligibility

Ages Eligible for Study:	2 Years to 11 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Children, ages 2-11, with a history of perennial allergic rhinitis

Criteria

Inclusion Criteria:

Children patients of both sexes aged between 2-11 years, of either gender and any race
Unequivocal history of perennial allergic rhinitis, including nasal congestion, sneezing, rhinorrhea, pruritus, and lacrimation
Minimum score for inclusion: 10
Capable of complying with the dosing regimen
Free of any clinically significant disease (other than allergic rhinitis)
Antihistamine must be justified by investigating doctor

Exclusion Criteria:

Patients with asthma who require chronic use of inhaled or systemic corticosteroids
History of frequent, clinically significant sinusitis or chronic purulent postnasal drip
Patients with rhinitis medicamentosa
History of hypersensitivity to desloratadine or any of its excipients
Doctor deems unsuitable

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P04299
Study First Received:	June 23, 2008
Last Updated:	June 23, 2008
ClinicalTrials.gov Identifier:	NCT00704769
Health Authority:	Indonesia: National Agency of Drug and Food Control

Study placed in the following topic categories:

Hypersensitivity
Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Rhinitis, Allergic, Perennial
Hypersensitivity, Immediate

Histamine phosphate
Rhinitis
Desloratadine
Histamine
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Neurotransmitter Agents
Histamine Antagonists
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Immune System Diseases
Physiological Effects of Drugs

Histamine Agents
Histamine H1 Antagonists
Histamine H1 Antagonists, Non-Sedating
Cholinergic Agents
Pharmacologic Actions
Nose Diseases

ClinicalTrials.gov processed this record on January 16, 2009