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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.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00704769
First received: June 23, 2008
Last updated: December 7, 2010
Last verified: December 2010
History of Changes
  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 (assigned by investigator as part of normal practice)

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • Adverse Events [ Time Frame: Minimum of 7 days after initiation of desloratadine ] [ Designated as safety issue: Yes ]
    An adverse event was defined in the protocol to include any untoward medical occurrence or unfavorable and unintended sign in a subject administered a pharmaceutical product (at any dose). Additionally, any event that is associated with or observed in conjunction with a product overdose (whether accidental or intentional) or a product abuse and/or withdrawal were also considered an adverse event. The investigator assessed the relationship of any adverse event as either unlikely, possibly, or probably related to the use of study drug based on available information and protocol guidelines.

  • General Clinical Response of Desloratadine Syrup Based on the Physician's Judgments [ Time Frame: Minimum of 7 days after initiation of desloratadine ] [ Designated as safety issue: No ]
    Physicians judged the subjects as good, excellent, fair, or poor.


Enrollment: 591
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 (assigned by investigator as part of normal practice)
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
Other Name: SCH 034117

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

No publications provided

Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00704769     History of Changes
Other Study ID Numbers: P04299
Study First Received: June 23, 2008
Results First Received: March 12, 2009
Last Updated: December 7, 2010
Health Authority: Indonesia: National Agency of Drug and Food Control

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Desloratadine
Loratadine
Cholinergic Antagonists
 Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Antipruritics
Dermatologic Agents
Therapeutic Uses
Anti-Allergic Agents

ClinicalTrials.gov processed this record on May 23, 2013