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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.
Sponsored by: Schering-Plough
Information provided by: Schering-Plough
ClinicalTrials.gov Identifier: NCT00780403
  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 IV

Drug Information available for: Cetirizine Cetirizine hydrochloride Descarboethoxyloratadine
U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
Official Title: A Multi-Center, Pediatric, Open-Label, Preference Study of Desloratadine 2.5 mg Reditab (SCH34117) Abd Zyrtec ® 5.0 mg Chewable Tablet Medications

Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • Whether the children prefer one medication over the other [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Relative degree of acceptability of the two attributes, taste and feeling in the mouth, for each medication. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

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
1: Active Comparator
Desloratadine
Drug: Desloratadine
desloratadine RediTabs, 1 tablet (2.5 mg),oral administration, single day
2: Active Comparator
Zyrtec
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 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: Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers: P04573
Study First Received: October 23, 2008
Last Updated: October 28, 2008
ClinicalTrials.gov Identifier: NCT00780403  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Hypersensitivity
Histamine phosphate
Cetirizine
Desloratadine
Histamine

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

ClinicalTrials.gov processed this record on January 16, 2009