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.
Sponsor:
Schering-Plough
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00780403
First received: October 23, 2008
Last updated: August 12, 2010
Last verified: August 2010
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Tracking Information | |
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First Received Date ICMJE | October 23, 2008 |
Last Updated Date | August 12, 2010 |
Start Date ICMJE | August 2005 |
Primary Completion Date | October 2005 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE |
Number of Subjects Who Preferred Desloratadine RediTab or Zyrtec Chewable Tablet. [ Time Frame: Following the second dose (8-10 minutes after the first dose) ] [ Designated as safety issue: No ] 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. |
Original Primary Outcome Measures ICMJE |
Whether the children prefer one medication over the other [ Time Frame: Day 1 ] [ Designated as safety issue: No ] |
Change History | Complete list of historical versions of study NCT00780403 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE | |
Original Secondary Outcome Measures ICMJE |
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 ] |
Current Other Outcome Measures ICMJE | |
Original Other Outcome Measures ICMJE | |
Descriptive Information | |
Brief Title ICMJE | 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) |
Official Title ICMJE | A Multi-Center, Pediatric, Open-Label, Preference Study of Desloratadine 2.5 mg Reditab (SCH34117) and Zyrtec ® 5.0 mg Chewable Tablet Medications |
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 |
Detailed Description | |
Study Type ICMJE | Interventional |
Study Phase | Phase 4 |
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label |
Condition ICMJE | Allergies |
Intervention ICMJE |
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Study Arm (s) |
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Publications * | |
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |
Recruitment Status ICMJE | Completed |
Enrollment ICMJE | 220 |
Completion Date | October 2005 |
Primary Completion Date | October 2005 (final data collection date for primary outcome measure) |
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both |
Ages | 6 Years to 11 Years |
Accepts Healthy Volunteers | Yes |
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
Location Countries ICMJE | |
Administrative Information | |
NCT Number ICMJE | NCT00780403 |
Other Study ID Numbers ICMJE | P04573 |
Has Data Monitoring Committee | No |
Responsible Party | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
Study Sponsor ICMJE | Schering-Plough |
Collaborators ICMJE | |
Investigators ICMJE | |
Information Provided By | Schering-Plough |
Verification Date | August 2010 |
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |