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

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ClinicalTrials.gov Identifier: NCT00704769
Recruitment Status : Completed
First Posted : June 25, 2008
Results First Posted : August 11, 2009
Last Update Posted : June 22, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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 or disease Intervention/treatment
Rhinitis Drug: Desloratadine (assigned by investigator as part of normal practice)

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

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Study Type : Observational
Actual Enrollment : 591 participants
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
Study Start Date : May 2005
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. Adverse Events [ Time Frame: Minimum of 7 days after initiation of desloratadine ]
    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.

  2. General Clinical Response of Desloratadine Syrup Based on the Physician's Judgments [ Time Frame: Minimum of 7 days after initiation of desloratadine ]
    Physicians judged the subjects as good, excellent, fair, or poor.



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Ages Eligible for Study:   2 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
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

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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00704769     History of Changes
Other Study ID Numbers: P04299
First Posted: June 25, 2008    Key Record Dates
Results First Posted: August 11, 2009
Last Update Posted: June 22, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Desloratadine
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents