A Study of Onset of Action of Loratadine and Fexofenadine in Participants With Seasonal Allergic Rhinitis (P08712)
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ClinicalTrials.gov Identifier: NCT01469234 |
Recruitment Status
:
Completed
First Posted
: November 10, 2011
Results First Posted
: March 22, 2013
Last Update Posted
: March 11, 2015
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Tracking Information | |||
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First Submitted Date ICMJE | November 8, 2011 | ||
First Posted Date ICMJE | November 10, 2011 | ||
Results First Submitted Date | February 12, 2013 | ||
Results First Posted Date | March 22, 2013 | ||
Last Update Posted Date | March 11, 2015 | ||
Study Start Date ICMJE | October 2011 | ||
Actual Primary Completion Date | November 2011 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
Mean Major Symptom Complex (MSC) Score by Post-Treatment Evaluation Time Point (From 180 Minutes to 300 Minutes) [ Time Frame: From time of sensitization (time 0) to end of visit (~8 hours) ] The MSC Score is calculated as the sum of 5 individual symptom scores for Runny Nose, Itchy Nose, Sneezing, Watery Eyes, and Itchy Eyes. Each individual symptom is rated on a 5-point scale of severity: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The total MSC score ranges from 0 - 25. Increasing scores are associated with increasing severity.
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Original Primary Outcome Measures ICMJE |
Participant Major Symptom Complex (MSC) Score [ Time Frame: From time of sensitization (time 0) to end of visit (~8 hours) ] MSC is calculated as the sum of scores for runny nose, itchy nose, sneezing, watery eyes, and itchy eyes. Each symptom is rated on a 5-point scale of severity: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living), for a total ranging from 0 - 25. Increasing scores are associated with increasing severity.
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Change History | Complete list of historical versions of study NCT01469234 on ClinicalTrials.gov Archive Site | ||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
Participant Individual Symptom Scores [ Time Frame: From time of sensitization (time 0) to end of visit (~8 hours) ] Individual symptom scores are rated on a 5-point scale of severity using the following scale 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living), for a total ranging from 0 - 25. Increasing scores are associated with increasing severity.
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Current Other Outcome Measures ICMJE | Not Provided | ||
Original Other Outcome Measures ICMJE | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | A Study of Onset of Action of Loratadine and Fexofenadine in Participants With Seasonal Allergic Rhinitis (P08712) | ||
Official Title ICMJE | A Double-Blind, Parallel, Randomized, Placebo Controlled Trial to Evaluate Onset of Action of Loratadine and Fexofenadine in Subjects With Seasonal Allergic Rhinitis in a Pollen Challenge Chamber | ||
Brief Summary | The purpose of this study is to determine the onset of action of two commercially available over-the-counter antihistamines (Loratadine and Fexofenadine) in a model of seasonal allergic rhinitis (SAR). Participants undergo sensitization exposures to Mountain Cedar (juniperus ashei) pollen in a Biogenics Research Chamber; those who demonstrate an adequate allergic response determined by the Major Symptom Complex (MSC) score will then receive drug. |
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Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase | Phase 4 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Rhinitis | ||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | ||
* 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 | ||
Actual Enrollment ICMJE |
255 | ||
Original Estimated Enrollment ICMJE |
450 | ||
Actual Study Completion Date | November 2011 | ||
Actual Primary Completion Date | November 2011 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
urine pregnancy test at Screening (Visit 1) and Visit 4 (prior to randomization) and agree to use (and/or have their partner use) 2 acceptable methods of birth control beginning at the Screening visit and throughout the study.
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | ||
Accepts Healthy Volunteers | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Not Provided | ||
Removed Location Countries | United States | ||
Administrative Information | |||
NCT Number ICMJE | NCT01469234 | ||
Other Study ID Numbers ICMJE | 18126 PT11-37 ( Other Identifier: Consumer Health Care ) P08712 ( Other Identifier: Merck ) |
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Has Data Monitoring Committee | No | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement | Not Provided | ||
Responsible Party | Bayer | ||
Study Sponsor ICMJE | Bayer | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Bayer | ||
Verification Date | February 2015 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |