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)

NCT00779116 | Completed Phase 4 Results

• 1 other identifier: P04574
• Study Type: interventional
• Target: 217
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Number of Subjects Who Preferred Desloratadine RediTab or Zyrtec Chewable Tablet.

  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.

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

Study Arms (2)

RediTab/Zyrtec

ACTIVE COMPARATOR

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; Drug: Zyrtec® (cetirizine)

Zyrtec/RediTab

ACTIVE COMPARATOR

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; Drug: Zyrtec® (cetirizine)

Interventions

Desloratadine DRUG

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

Also known as: Clarinex, SCH 034117

RediTab/Zyrtec; Zyrtec/RediTab

Zyrtec® (cetirizine) DRUG

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

RediTab/Zyrtec; Zyrtec/RediTab

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• 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.

  PMID: 23282979 RESULT

MeSH Terms

Conditions

Hypersensitivity

Interventions

desloratadine; Cetirizine

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Hydroxyzine; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2008
• First Posted: October 24, 2008
• Study Start: September 1, 2005
• Primary Completion: October 1, 2005
• Study Completion: October 1, 2005
• Last Updated: February 9, 2022
• Results First Posted: July 5, 2010

Record last verified: 2022-02