Response of Desloratadine Syrup in the Relief of Symptoms Associated With Perennial Allergic Rhinitis in Pediatric Patients (Study P04299)
Study Details
Study Description
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 | Phase |
|---|---|---|
|
Detailed Description
Children, ages 2-11, with a history of perennial allergic rhinitis
Study Design
Arms and Interventions
| Arm | 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 Names:
|
Outcome Measures
Primary Outcome Measures
- Adverse Events [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.
- General Clinical Response of Desloratadine Syrup Based on the Physician's Judgments [Minimum of 7 days after initiation of desloratadine]
Physicians judged the subjects as good, excellent, fair, or poor.
Eligibility Criteria
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
Locations
No locations specified.Sponsors and Collaborators
- Organon and Co
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- P04299
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Desloratadine |
|---|---|
| Arm/Group Description | |
| Period Title: Overall Study | |
| STARTED | 591 |
| COMPLETED | 591 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Desloratadine |
|---|---|
| Arm/Group Description | |
| Overall Participants | 591 |
| Age (Count of Participants) | |
| <=18 years |
591
100%
|
| Between 18 and 65 years |
0
0%
|
| >=65 years |
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
5.28
(2.92)
|
| Sex/Gender, Customized (participants) [Number] | |
| Female |
238
40.3%
|
| Male |
345
58.4%
|
| Missing Information for sex |
8
1.4%
|
| Region of Enrollment (participants) [Number] | |
| Indonesia |
591
100%
|
Outcome Measures
| Title | Adverse Events |
|---|---|
| Description | 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. |
| Time Frame | Minimum of 7 days after initiation of desloratadine |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Desloratadine |
|---|---|
| Arm/Group Description | |
| Measure Participants | 591 |
| Nausea |
3
0.5%
|
| Dizziness |
1
0.2%
|
| Title | General Clinical Response of Desloratadine Syrup Based on the Physician's Judgments |
|---|---|
| Description | Physicians judged the subjects as good, excellent, fair, or poor. |
| Time Frame | Minimum of 7 days after initiation of desloratadine |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Desloratadine |
|---|---|
| Arm/Group Description | |
| Measure Participants | 591 |
| Good |
350
59.2%
|
| Excellent |
159
26.9%
|
| Fair |
50
8.5%
|
| Poor |
11
1.9%
|
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Desloratadine | |
| Arm/Group Description | ||
All Cause Mortality |
||
| Desloratadine | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Desloratadine | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/591 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Desloratadine | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/591 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Results Point of Contact
| Name/Title | Senior Vice President, Global Clinical Development |
|---|---|
| Organization | Merck Sharp & Dohme Corp. |
| Phone | |
| ClinicalTrialsDisclosure@merck.com |
- P04299