Allergies
Conditions
Brief 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.
Interventions
DRUGDesloratadine
SCH 34117: desloratadine RediTabs, 1 tablet (2.5 mg), oral administration, single dose, single day
Zyrtec® (cetirizine) Chewable Tablets, 1 tablet (5 mg), oral administration, single dose, single day
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Who Preferred Desloratadine RediTab or Zyrtec Chewable Tablet. | Following the second dose (8-10 minutes after the first dose) | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Total Population All randomized subjects | 217 |
| Total | 217 |
Baseline characteristics
| Characteristic | Total Population |
|---|---|
| Age, Continuous | 8.6 years STANDARD_DEVIATION 1.69 |
| Sex: Female, Male Female | 113 Participants |
| Sex: Female, Male Male | 104 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 109 | 0 / 108 |
| serious Total, serious adverse events | 0 / 109 | 0 / 108 |
Outcome results
Primary
Number of Subjects Who Preferred Desloratadine RediTab or Zyrtec Chewable Tablet.
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.
Time frame: Following the second dose (8-10 minutes after the first dose)
Population: All randomized subjects received either Reditab or Zyrtec, followed 8-10 minutes later by the opposite study drug (Reditab followed by Zyrtec or Zyrtec followed by Reditab).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RediTab | Number of Subjects Who Preferred Desloratadine RediTab or Zyrtec Chewable Tablet. | 150 Participants |
| Zyrtec | Number of Subjects Who Preferred Desloratadine RediTab or Zyrtec Chewable Tablet. | 39 Participants |
| No Preference | Number of Subjects Who Preferred Desloratadine RediTab or Zyrtec Chewable Tablet. | 28 Participants |
Comparison: The Mainland-Gart test was applied to the preference rates in the subjects who showed a preference, to assess the difference in preference rates between RediTab and Zyrtec.p-value: <0.0001Mainland-Gart Test