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)

NCT ID: NCT00779116

Last Updated: 2022-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 217 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2005-10-31

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.

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

SCH 34117: desloratadine RediTabs, 1 tablet (2.5 mg), oral administration, single dose, single day

Zyrtec® (cetirizine)

Intervention Type: DRUG

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

SCH 34117: desloratadine RediTabs, 1 tablet (2.5 mg), oral administration, single dose, single day

Zyrtec® (cetirizine)

Intervention Type: DRUG

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

Interventions

Desloratadine

SCH 34117: desloratadine RediTabs, 1 tablet (2.5 mg), oral administration, single dose, single day

Intervention Type: DRUG

Zyrtec® (cetirizine)

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

Intervention Type: DRUG

Other Intervention Names

Clarinex, 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.
• 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.

• 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

References

Tassinari P, Suarez NR, Centeno J, Velasquez JV, Aguirre-Mariscal H, Gonzalezdiaz SN, Jerves AF; LA Desloratadine Study Group. Desloratadine therapy improves allergic rhinitis symptoms in latin american children aged 6 to 12 years. World Allergy Organ J. 2009 Apr;2(4):42-8. doi: 10.1097/WOX.0b013e31819cdfdb.

Reference Type: RESULT

PMID: 23282979 (View on PubMed)

Other Identifiers

P04574

Identifier Type: -

Identifier Source: org_study_id