A Study of Onset of Action of Loratadine and Fexofenadine in Participants With Seasonal Allergic Rhinitis (P08712)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01469234
First received: November 8, 2011
Last updated: February 28, 2014
Last verified: February 2014
Results First Received: February 12, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Rhinitis
Interventions: Drug: loratadine
Drug: fexofenadine
Drug: placebo to loratadine
Drug: placebo to fexofenadine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Loratadine Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
Fexofenadine Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
Placebo Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.

Participant Flow:   Overall Study
    Loratadine     Fexofenadine     Placebo  
STARTED     85     85     85  
COMPLETED     85     85     85  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Loratadine Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
Fexofenadine Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
Placebo Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
Total Total of all reporting groups

Baseline Measures
    Loratadine     Fexofenadine     Placebo     Total  
Number of Participants  
[units: participants]
  85     85     85     255  
Age  
[units: years]
Mean ± Standard Deviation
  41.5  ± 13.52     43.1  ± 12.21     40.6  ± 12.56     41.7  ± 12.77  
Gender  
[units: participants]
       
Female     51     53     53     157  
Male     34     32     32     98  



  Outcome Measures
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1.  Primary:   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) ]

2.  Secondary:   Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point   [ Time Frame: From time of sensitization (time 0) to end of visit (~8 hours) ]

3.  Secondary:   Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point   [ Time Frame: From time of sensitization (time 0) to end of visit (~8 hours) ]

4.  Secondary:   Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point   [ Time Frame: From time of sensitization (time 0) to end of visit (~8 hours) ]

5.  Secondary:   Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point   [ Time Frame: From time of sensitization (time 0) to end of visit (~8 hours) ]

6.  Secondary:   Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point   [ Time Frame: From time of sensitization (time 0) to end of visit (~8 hours) ]

7.  Secondary:   Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point   [ Time Frame: From time of sensitization (time 0) to end of visit (~8 hours) ]

8.  Secondary:   Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point   [ Time Frame: From time of sensitization (time 0) to end of visit (~8 hours) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01469234     History of Changes
Other Study ID Numbers: P08712, PT11-37
Study First Received: November 8, 2011
Results First Received: February 12, 2013
Last Updated: February 28, 2014
Health Authority: United States: Food and Drug Administration