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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 P04574)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00779116
First received: October 23, 2008
Last updated: November 3, 2014
Last verified: November 2014
  Purpose

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.


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:


Further study details as provided by Merck Sharp & Dohme Corp.:

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: 217
Study Start Date: September 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
SCH 34117: desloratadine RediTabs, 1 tablet (2.5 mg), oral administration, single dose, single day
Other Name: Clarinex, SCH 034117
Drug: Zyrtec® (cetirizine)
Zyrtec® (cetirizine) Chewable Tablets, 1 tablet (5 mg), oral administration, single dose, 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
SCH 34117: desloratadine RediTabs, 1 tablet (2.5 mg), oral administration, single dose, single day
Other Name: Clarinex, SCH 034117
Drug: Zyrtec® (cetirizine)
Zyrtec® (cetirizine) Chewable Tablets, 1 tablet (5 mg), oral administration, single dose, 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.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00779116     History of Changes
Other Study ID Numbers: P04574
Study First Received: October 23, 2008
Results First Received: February 17, 2010
Last Updated: November 3, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cetirizine
Desloratadine
Anti-Allergic Agents
Cholinergic Agents
Cholinergic Antagonists
Histamine Agents
Histamine Antagonists
Histamine H1 Antagonists
Histamine H1 Antagonists, Non-Sedating
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014