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| Tracking Information | |
|---|---|
| First Received Date ICMJE | November 29, 2006 |
| Last Updated Date | September 25, 2009 |
| Start Date ICMJE | August 2006 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE |
The Change From Baseline in the 12-hour AM/PM-PRIOR (Reflective) Total 5 Symptom Score (T5SS) From Subject Daily Diaries Averaged Over Treatment Days 1 to 15 [ Time Frame: 15 days ] [ Designated as safety issue: No ] |
| Original Primary Outcome Measures ICMJE |
The change from baseline in the 12-hour AM/PM-PRIOR (reflective) total 5 symptom score (T5SS) from subject daily diaries averaged over treatment Days 1 to 15. AM/PM is the average of separate morning (AM) and evening (PM) evaluations. [ Time Frame: 15 days ] |
| Change History | Complete list of historical versions of study NCT00406783 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE |
Change From Baseline in the Rhinoconjunctivitis Quality of Life Questionnaire-Standardized Version (RQLQ-S) at the Final Visit [ Time Frame: 15 days ] [ Designated as safety issue: No ] |
| Original Secondary Outcome Measures ICMJE |
Change from Baseline in the RQLQ-S at the Final Visit. The RQLQ-S will only be completed for subjects >=18 years of age and where available in the local language. [ Time Frame: 15 days ] |
| Descriptive Information | |
| Brief Title ICMJE | Study for the Treatment of Intermittent Allergic Rhinitis With Desloratadine (Study P04683AM1)(COMPLETED) |
| Official Title ICMJE | Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter/Multinational, Efficacy and Safety Study of Desloratadine 5 mg in the Treatment of Subjects With Allergic Rhinitis Who Meet the Criteria for Intermittent Allergic Rhinitis (IAR) |
| Brief Summary | This study will investigate the effectiveness of desloratadine in treating subjects with allergic rhinitis (AR) who meet the criteria for intermittent allergic rhinitis. |
| Detailed Description | |
| Study Phase | Phase III |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 547 |
| Completion Date | November 2007 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | Inclusion Criteria: The subject must meet ALL of the criteria listed below for entry:
Exclusion Criteria: The subject will be excluded from entry if ANY of the criteria listed below are met:
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| Gender | Both |
| Ages | 12 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | |
| Administrative Information | |
| NCT ID ICMJE | NCT00406783 |
| Responsible Party | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| Study ID Numbers ICMJE | P04683 |
| Study Sponsor ICMJE | Schering-Plough |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | Schering-Plough |
| Verification Date | September 2009 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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