Trial Outcomes & Findings for Multi-Center, Pediatric, Open-Label, Preference Study of Desloratadine 2.5 mg Reditab (SCH34117) and Zyrtec ® 5.0 mg Chewable Tablet Medications (Study P04573) (Completed) (NCT NCT00780403)

Last Updated: 2022-02-09

Results Overview

A product preference questionnaire was completed after the administration of the second study drug. An interviewer instructed the subject "now that you have tasted the two tablets, show us which tablet you like more" and the subject then marked which tablet he/she preferred. If the subject had no preference, the response was recorded accordingly.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

220 participants

Primary outcome timeframe

Following the second dose (8-10 minutes after the first dose)

Results posted on

2022-02-09

Participant Flow

Participant milestones

Participant milestones
Measure	RediTab/Zyrtec Subjects received a single dose of desloratadine Reditab followed 8-10 minutes later by a single dose of Zyrtec chewable tablet (first and second intervention period).	Zyrtec/RediTab Subjects received a single dose of Zyrtec chewable tablet followed 8-10 minutes later by a single dose of desloratadine RediTab (first and second intervention period).
First Intervention STARTED	109	111
First Intervention COMPLETED	109	111
First Intervention NOT COMPLETED	0	0
Interval Between Doses (8-10 Minutes) STARTED	109	111
Interval Between Doses (8-10 Minutes) COMPLETED	109	111
Interval Between Doses (8-10 Minutes) NOT COMPLETED	0	0
Second Intervention STARTED	109	111
Second Intervention COMPLETED	109	111
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Multi-Center, Pediatric, Open-Label, Preference Study of Desloratadine 2.5 mg Reditab (SCH34117) and Zyrtec ® 5.0 mg Chewable Tablet Medications (Study P04573) (Completed)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total Population n=220 Participants All randomized subjects.
Age, Continuous	8.9 years STANDARD_DEVIATION 1.65 • n=93 Participants
Sex: Female, Male Female	109 Participants n=93 Participants
Sex: Female, Male Male	111 Participants n=93 Participants

PRIMARY outcome

Timeframe: Following the second dose (8-10 minutes after the first dose)

Population: All randomized subjects received either Reditab or Zyrtec, followed 8-10 minutes later by the opposite study drug (Reditab followed by Zyrtec or Zyrtec followed by Reditab).

Outcome measures

Outcome measures
Measure	RediTab n=220 Participants All randomized subjects.	Zyrtec n=220 Participants All randomized subjects.	No Preference n=220 Participants All randomized subjects.
Number of Subjects Who Preferred Desloratadine RediTab or Zyrtec Chewable Tablet.	149 participants	33 participants	38 participants

Adverse Events

RediTab/Zyrtec

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Zyrtec/RediTab

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 The only disclosure restriction on the PI is that the sponsor can review results communications prior to release and can embargo communications regarding trial results for a period that is less than or equal to 45 days from the time submitted to the sponsor for review. If the parties disagree on the communication, the investigator and sponsor's representative will meet for the purpose of making a good faith effort to discuss and resolve any such issues or disagreement.
Publication restrictions are in place

Restriction type: OTHER