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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)

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00780403
First received: October 23, 2008
Last updated: August 12, 2010
Last verified: August 2010
History of Changes
  Purpose

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 Intervention Phase
Allergies
 Drug: Desloratadine
Drug: Zyrtec® (cetirizine)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • Number of Subjects Who Preferred Desloratadine RediTab or Zyrtec Chewable Tablet. [ Time Frame: Following the second dose (8-10 minutes after the first dose) ] [ Designated as safety issue: No ]
    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.


Enrollment: 220
Study Start Date: August 2005
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   6 Years to 11 Years
Genders Eligible for Study:   Both
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

No publications provided

Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00780403     History of Changes
Other Study ID Numbers: P04573
Study First Received: October 23, 2008
Results First Received: February 17, 2010
Last Updated: August 12, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cetirizine
Loratadine
Desloratadine
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
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
Antipruritics
Dermatologic Agents

ClinicalTrials.gov processed this record on May 16, 2013