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

NCT00704769 | Completed Results

• 1 other identifier: P04299
• Study Type: observational
• Target: 591
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rhinitis

Outcome Measures

Primary Outcomes (2)

• Adverse Events

  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.

  Minimum of 7 days after initiation of desloratadine

• General Clinical Response of Desloratadine Syrup Based on the Physician's Judgments

  Physicians judged the subjects as good, excellent, fair, or poor.

  Minimum of 7 days after initiation of desloratadine

Study Arms (1)

1

Children with a history of perennial allergic rhinitis

Drug: Desloratadine (assigned by investigator as part of normal practice)

Interventions

Desloratadine (assigned by investigator as part of normal practice) DRUG

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

Also known as: SCH 034117

1

Eligibility Criteria

• Age: 2 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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
• Capable of complying with the dosing regimen
• Free of any clinically significant disease (other than allergic rhinitis)
• Antihistamine must be justified by investigating doctor

You may not qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead

MeSH Terms

Conditions

Rhinitis

Interventions

desloratadine

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic 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: June 23, 2008
• First Posted: June 25, 2008
• Study Start: May 1, 2005
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: February 9, 2022
• Results First Posted: August 11, 2009

Record last verified: 2022-02