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Phase 4 Completed N=220 Randomized Other

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)

Source: ClinicalTrials.gov NCT00780403 ↗
Enrolled (actual)
220
Serious AEs
0.0%
Results posted
Jul 2010
Primary outcomePrimary: Number of Subjects Who Preferred Desloratadine RediTab or Zyrtec Chewable Tablet. — 149; 33; 38 participants — p=<0.0001

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

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Subjects Who Preferred Desloratadine RediTab or Zyrtec Chewable Tablet.
149; 33; 38 <0.0001 sig

Eligibility 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00780403). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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