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)
Study Details
Study Description
Brief 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
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
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
desloratadine RediTabs, 1 tablet (2.5 mg),oral administration, single day
Other Names:
Drug: Zyrtec® (cetirizine)
Zyrtec® (cetirizine) Chewable Tablets, 1 tablet (5 mg), oral administration, 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
desloratadine RediTabs, 1 tablet (2.5 mg),oral administration, single day
Other Names:
Drug: Zyrtec® (cetirizine)
Zyrtec® (cetirizine) Chewable Tablets, 1 tablet (5 mg), oral administration, single day
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
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
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6-11 years old, either sex, either race
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If female, subject to be premenarcheal
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Willing to avoid eating, drinking, gum chewing, and teeth brushing for one hour prior to enrollment.
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Free of any clinically significant disease that would interfere with study evaluations, including allergic rhinitis and respiratory infections.
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Able to adhere to the dosing and visit schedules
Exclusion Criteria:
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If female, subject who was pregnant, intended to become pregnant during the study or nursing.
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Subject had used any investigational product within 30 days prior to enrollment.
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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.
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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.).
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Subject was participating in any other clinical study(ies).
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Subject was part of the staff or a family member of the staff personnel directly involved with this study.
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Subject was allergic to or has sensitivity to the study drug or its excipients.
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Subject had a history of allergic reaction to prescription and/or over the counter (OTC) medications and/or food products.
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Subject had used any antihistamines within 24 hours prior to tasting as outlined in Section 9.4.7.
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Subject used sedatives, tranquilizers, or monoamine oxidase inhibitor drugs.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Organon and Co
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- P04573
Study Results
Participant Flow
Recruitment Details | |
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Pre-assignment Detail |
Arm/Group Title | RediTab/Zyrtec | Zyrtec/RediTab |
---|---|---|
Arm/Group Description | Subjects received a single dose of desloratadine Reditab followed 8-10 minutes later by a single dose of Zyrtec chewable tablet (first and second intervention period). | Subjects received a single dose of Zyrtec chewable tablet followed 8-10 minutes later by a single dose of desloratadine RediTab (first and second intervention period). |
Period Title: First Intervention | ||
STARTED | 109 | 111 |
COMPLETED | 109 | 111 |
NOT COMPLETED | 0 | 0 |
Period Title: First Intervention | ||
STARTED | 109 | 111 |
COMPLETED | 109 | 111 |
NOT COMPLETED | 0 | 0 |
Period Title: First Intervention | ||
STARTED | 109 | 111 |
COMPLETED | 109 | 111 |
NOT COMPLETED | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Total Population |
---|---|
Arm/Group Description | All randomized subjects. |
Overall Participants | 220 |
Age (years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [years] |
8.9
(1.65)
|
Sex: Female, Male (Count of Participants) | |
Female |
109
49.5%
|
Male |
111
50.5%
|
Outcome Measures
Title | Number of Subjects Who Preferred Desloratadine RediTab or Zyrtec Chewable Tablet. |
---|---|
Description | 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) |
Outcome Measure Data
Analysis Population Description |
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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/Group Title | RediTab | Zyrtec | No Preference |
---|---|---|---|
Arm/Group Description | All randomized subjects. | All randomized subjects. | All randomized subjects. |
Measure Participants | 220 | 220 | 220 |
Number [participants] |
149
67.7%
|
33
NaN
|
38
NaN
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | RediTab, Zyrtec |
---|---|---|
Comments | 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. | |
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.0001 |
Comments | Statistical tests were performed at the significance level of 5%, without multiplicity adjustment. | |
Method | Mainland-Gart Test | |
Comments | The p-value was derived from Mainland-Gart Test applied to a 2 (treatment sequence) by 2 (preferred period) contingency table. |
Adverse Events
Time Frame | 1 day | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | RediTab/Zyrtec | Zyrtec/RediTab | ||
Arm/Group Description | Subjects received a single dose of desloratadine Reditab followed 8-10 minutes later by a single dose of Zyrtec chewable tablet (first and second intervention period). | Subjects received a single dose of Zyrtec chewable tablet followed 8-10 minutes later by a single dose of desloratadine RediTab (first and second intervention period). | ||
All Cause Mortality |
||||
RediTab/Zyrtec | Zyrtec/RediTab | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
RediTab/Zyrtec | Zyrtec/RediTab | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/109 (0%) | 0/111 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
RediTab/Zyrtec | Zyrtec/RediTab | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/109 (0%) | 0/111 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to release and can embargo communications regarding trial results for a period that is less than or equal to 45 days from the time submitted to the sponsor for review. If the parties disagree on the communication, the investigator and sponsor's representative will meet for the purpose of making a good faith effort to discuss and resolve any such issues or disagreement.
Results Point of Contact
Name/Title | Senior Vice President, Global Clinical Development |
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Organization | Merck Sharp & Dohme Corp. |
Phone | |
ClinicalTrialsDisclosure@merck.com |
- P04573