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 ID: NCT00780403

Last Updated: 2022-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2005-10-31

Brief Summary

The primary objective of this study was to determine whether children ages 6-11 years prefer desloratadine RediTabs (2.5 mg) or a marketed competitor (Zyrtec® 5 mg Chewable Tablets). The secondary objectives of this study were to compare acceptance of the two attributes, taste and feeling in the mouth, of desloratadine 2.5 mg RediTabs and Zyrtec® 5 mg Chewable Tablets

Conditions

Allergies

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Desloratadine

Intervention Type: DRUG

desloratadine RediTabs, 1 tablet (2.5 mg),oral administration, single day

Zyrtec® (cetirizine)

Intervention Type: DRUG

Zyrtec® (cetirizine) Chewable Tablets, 1 tablet (5 mg), oral administration, single day

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.

Group Type: ACTIVE_COMPARATOR

Desloratadine

Intervention Type: DRUG

desloratadine RediTabs, 1 tablet (2.5 mg),oral administration, single day

Zyrtec® (cetirizine)

Intervention Type: DRUG

Zyrtec® (cetirizine) Chewable Tablets, 1 tablet (5 mg), oral administration, single day

Interventions

Desloratadine

desloratadine RediTabs, 1 tablet (2.5 mg),oral administration, single day

Intervention Type: DRUG

Zyrtec® (cetirizine)

Zyrtec® (cetirizine) Chewable Tablets, 1 tablet (5 mg), oral administration, single day

Intervention Type: DRUG

Other Intervention Names

SCH 034117

Eligibility Criteria

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
• 6-11 years old, either sex, either race
• If female, subject to be premenarcheal
• Willing to avoid eating, drinking, gum chewing, and teeth brushing for one hour prior to enrollment.
• Free of any clinically significant disease that would interfere with study evaluations, including allergic rhinitis and respiratory infections.
• 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 over the counter (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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

P04573

Identifier Type: -

Identifier Source: org_study_id