Multi-center, Pediatric, Open-label, Preference Study of Desloratadine 2.5 mg Reditab (SCH34117) and Zyrtec 5.0 mg Chewable Tablet Medications (Study P04574)(COMPLETED)

• Sponsor: Organon and Co (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00779116
• Collaborator: (none)
• Enrollment: 217
• Arms: 2
• Duration (Days): 30

Study Details

Study Description

Brief Summary

This was a randomized, open-label, 2-way cross-over study, comparing desloratadine RediTab 2.5 mg to a marketed chewable antihistamine oral medication (Zyrtec® 5 mg

Chewable Tablet). Subject preference for one product or the other was determined. Acceptability of product attributes (Taste and Feeling in the Mouth) was rated using a "smile" face scale.

Condition or Disease	Intervention/Treatment	Phase
Allergies	Drug: Desloratadine; Drug: Zyrtec® (cetirizine)	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 217 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: A Multi-center, Pediatric, Open-label, Preference Study of Desloratadine 2.5 mg Reditab (SCH34117) and Zyrtec 5.0 mg Chewable Tablet Medications
• Study Start Date: Sep 1, 2005
• Actual Primary Completion Date: Oct 1, 2005
• Actual Study Completion Date: Oct 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: RediTab/Zyrtec Subjects received a single dose of desloratadine RediTab followed 8-10 minutes later by a single dose of Zyrtec chewable tablet followed thereafter by a statement of preference.	Drug: Desloratadine; SCH 34117: desloratadine RediTabs, 1 tablet (2.5 mg), oral administration, single dose, single day; Other Names: Clarinex, SCH 034117 ; Drug: Zyrtec® (cetirizine); Zyrtec® (cetirizine) Chewable Tablets, 1 tablet (5 mg), oral administration, single dose, single day
Active Comparator: Zyrtec/RediTab Subjects received a single dose of Zyrtec chewable tablet followed 8-10 minutes later by a single dose of desloratadine RediTab followed thereafter by a statement of preference.	Drug: Desloratadine; SCH 34117: desloratadine RediTabs, 1 tablet (2.5 mg), oral administration, single dose, single day; Other Names: Clarinex, SCH 034117 ; Drug: Zyrtec® (cetirizine); Zyrtec® (cetirizine) Chewable Tablets, 1 tablet (5 mg), oral administration, single dose, single day

Outcome Measures

Primary Outcome Measures

1. Number of Subjects Who Preferred Desloratadine RediTab or Zyrtec Chewable Tablet. [Following the second dose (8-10 minutes after the first dose)]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 11 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Subject, and the parent/guardian of the subject, was to have demonstrated their willingness to participate in the study and comply with its procedures by signing a written Informed Consent.

• Subject was to be 6-11 years of age, of either sex and of any race.

• If female, subject was to be premenarcheal.

• Subject was to be willing to avoid eating, drinking, gum chewing, and teeth brushing for one hour prior to enrollment.

• Subject was to be free of any clinically significant disease that would interfere with study evaluations, including allergic rhinitis and respiratory infections.

• Subject was to have understood and been able to adhere to the dosing and visit schedules.

Exclusion Criteria:

• If female, subject who was pregnant, intended to become pregnant during the study or nursing.

• Subject had used any investigational product within 30 days prior to enrollment.

• Subject had any of the following clinical conditions: history of any significant medical conditions (based on reporting by parent or guardian): e.g., diabetes, heart disease, liver disease, kidney disease, breathing problems, cough with excessive phlegm, or persistent or chronic cough.

• Subject had a current medical condition that, in the opinion of the Investigator or designee, may interfere with the ability to discriminate taste (e.g., common cold, sinus infection, bronchial infection, allergic rhinitis, etc.).

• Subject was participating in any other clinical study(ies).

• Subject was part of the staff or a family member of the staff personnel directly involved with this study.

• Subject was allergic to or has sensitivity to the study drug or its excipients.

• Subject had a history of allergic reaction to prescription and/or OTC medications and/or food products.

• Subject had used any antihistamines within 24 hours prior to tasting as outlined in Section 9.4.7.

• Subject used sedatives, tranquilizers, or monoamine oxidase inhibitor drugs.

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.

• Responsible Party: Organon and Co
• ClinicalTrials.gov Identifier: NCT00779116
• Other Study ID Numbers: P04574
• First Posted: Oct 24, 2008
• Last Update Posted: Feb 9, 2022
• Last Verified: Feb 1, 2022

• Additional relevant MeSH terms: Cetirizine; Desloratadine

Study Results

Participant Flow

Arm/Group Title	RediTab/Zyrtec	Zyrtec/RediTab
Arm/Group Description	Subjects received a single dose of desloratadine Reditab followed 8-10 minutes later by a single dose of Zyrtec chewable tablet.	Subjects received a single dose of Zyrtec chewable tablet followed 8-10 minutes later by a single dose of desloratadine Reditab.
Period Title: First Intervention
STARTED	109	108
COMPLETED	109	108
NOT COMPLETED	0	0
Period Title: First Intervention
STARTED	109	108
COMPLETED	109	108
NOT COMPLETED	0	0
Period Title: First Intervention
STARTED	109	108
COMPLETED	109	108
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Total Population
Arm/Group Description	All randomized subjects
Overall Participants	217
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	8.6 (1.69)
Sex: Female, Male (Count of Participants)
Female	113 52.1%
Male	104 47.9%

Outcome Measures

1. Primary Outcome

Title	Number of Subjects Who Preferred Desloratadine RediTab or Zyrtec Chewable Tablet.
Description	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.
Time Frame	Following the second dose (8-10 minutes after the first dose)

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	RediTab	Zyrtec	No Preference
Arm/Group Description	All randomized subjects.	All randomized subjects.	All randomized subjects.
Measure Participants	217	217	217
Number [Participants]	150 69.1%	39 NaN	28 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	RediTab, Zyrtec
	Comments	The Mainland-Gart test was applied to the preference rates in the subjects who showed a preference, to assess the difference in preference rates between RediTab and Zyrtec.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Statistical tests were performed atthe significance level of 5%, without multiplicity adjustment.
	Method	Mainland-Gart Test
	Comments	The p-value was derived from Mainland-Gart Test applied to a 2 (treatment sequence) by 2 (preferred period) contingency table.

Adverse Events

Time Frame	1 day
Arm/Group Title	RediTab/Zyrtec		Zyrtec/RediTab
Arm/Group Description	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).		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).
All Cause Mortality
	RediTab/Zyrtec		Zyrtec/RediTab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	RediTab/Zyrtec		Zyrtec/RediTab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/109 (0%)		0/108 (0%)
Other (Not Including Serious) Adverse Events
	RediTab/Zyrtec		Zyrtec/RediTab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/109 (0%)		0/108 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.