Trial Outcomes & Findings for Response of Desloratadine Syrup in the Relief of Symptoms Associated With Perennial Allergic Rhinitis in Pediatric Patients (Study P04299) (NCT NCT00704769)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

591 participants

Primary outcome timeframe

Minimum of 7 days after initiation of desloratadine

Results posted on

2022-02-09

Participant Flow

Participant milestones

Participant milestones
Measure	Desloratadine
Overall Study STARTED	591
Overall Study COMPLETED	591
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Desloratadine n=591 Participants
Age, Categorical <=18 years	591 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	5.28 years STANDARD_DEVIATION 2.92 • n=5 Participants
Sex/Gender, Customized Female	238 participants n=5 Participants
Sex/Gender, Customized Male	345 participants n=5 Participants
Sex/Gender, Customized Missing Information for sex	8 participants n=5 Participants
Region of Enrollment Indonesia	591 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Desloratadine n=591 Participants
Adverse Events Nausea	3 Participants
Adverse Events Dizziness	1 Participants

PRIMARY outcome

Timeframe: Minimum of 7 days after initiation of desloratadine

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

Outcome measures

Outcome measures
Measure	Desloratadine n=591 Participants
General Clinical Response of Desloratadine Syrup Based on the Physician's Judgments Good	350 Participants
General Clinical Response of Desloratadine Syrup Based on the Physician's Judgments Excellent	159 Participants
General Clinical Response of Desloratadine Syrup Based on the Physician's Judgments Fair	50 Participants
General Clinical Response of Desloratadine Syrup Based on the Physician's Judgments Poor	11 Participants

Adverse Events

Desloratadine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER