Phase 4
Completed N=217
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)
Source: ClinicalTrials.gov NCT00779116 ↗Enrolled (actual)
217
Serious AEs
0.0%
Results posted
Jul 2010
Primary outcomePrimary: Number of Subjects Who Preferred Desloratadine RediTab or Zyrtec Chewable Tablet. — 150; 39; 28 Participants — p=<0.0001
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Who Preferred Desloratadine RediTab or Zyrtec Chewable Tablet. |
150; 39; 28 | <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.
- 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.
Data sourced from ClinicalTrials.gov (NCT00779116). 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.