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)

• ClinicalTrials.gov Identifier: NCT00780403
• Recruitment Status: Completed
• First Posted: October 27, 2008
• Results First Posted: July 30, 2010
• Last Update Posted: February 9, 2022
• Sponsor: Organon and Co
• Information provided by (Responsible Party): Organon and Co

Study Description

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

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 220 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: August 2005
• Actual Primary Completion Date: October 2005
• Actual Study Completion Date: October 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; desloratadine RediTabs, 1 tablet (2.5 mg),oral administration, single day; Other Name: SCH 034117; Drug: Zyrtec® (cetirizine); Zyrtec® (cetirizine) Chewable Tablets, 1 tablet (5 mg), oral administration, 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; desloratadine RediTabs, 1 tablet (2.5 mg),oral administration, single day; Other Name: SCH 034117; Drug: Zyrtec® (cetirizine); Zyrtec® (cetirizine) Chewable Tablets, 1 tablet (5 mg), oral administration, single day

Outcome Measures

Primary Outcome Measures :

1. Number of Subjects Who Preferred Desloratadine RediTab or Zyrtec Chewable Tablet. [ Time Frame: 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

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

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Organon and Co
• ClinicalTrials.gov Identifier: NCT00780403
• Other Study ID Numbers: P04573
• First Posted: October 27, 2008
• Results First Posted: July 30, 2010
• Last Update Posted: February 9, 2022
• Last Verified: February 2022

Additional relevant MeSH terms:

Cetirizine; Desloratadine; Anti-Allergic Agents; Histamine H1 Antagonists, Non-Sedating; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Cholinergic Antagonists; Cholinergic Agents