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Study for the Treatment of Persistent Allergic Rhinitis With Desloratadine (Study P04684AM2)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00405964
First received: November 30, 2006
Last updated: October 22, 2010
Last verified: October 2010
History of Changes
Results First Received: March 25, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Allergic Rhinitis
Interventions: Drug: 5-mg Desloratadine
Drug: Placebo tablet

  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
5-mg Desloratadine Tablet Desloratadine 5 mg orally daily. Dosing was to be in the morning (AM) within 1 hour of awakening.
Placebo Tablet Matching placebo, orally daily.

Participant Flow:   Overall Study
    5-mg Desloratadine Tablet     Placebo Tablet  
STARTED     360     356  
COMPLETED     301     261  
NOT COMPLETED     59     95  
Treatment Failure                 17                 45  
Adverse Event                 7                 16  
Lost to Follow-up                 5                 5  
Withdrawal by Subject                 19                 23  
Protocol Violation                 11                 6  



  Baseline Characteristics
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Reporting Groups
  Description
5-mg Desloratadine Tablet Desloratadine 5 mg orally daily. Dosing was to be in the morning (AM) within 1 hour of awakening.
Placebo Tablet Matching placebo, orally daily.
Total Total of all reporting groups

Baseline Measures
    5-mg Desloratadine Tablet     Placebo Tablet     Total  
Number of Participants  
[units: participants]
 		  360     356     716  
Age  
[units: participants]
 		     
<=18 years     9     9     18  
Between 18 and 65 years     348     341     689  
>=65 years     3     6     9  
Age  
[units: years]
Mean ± Standard Deviation 		  34.0  ± 12.1     33.9  ± 12.3     33.9  ± 12.2  
Gender  
[units: participants]
 		     
Female     208     198     406  
Male     152     158     310  



  Outcome Measures
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1.  Primary:   Change From Baseline in Participant's AM/PM PRIOR Total 5 Symptom Score (T5SS) Over Days 1 to 29 of Treatment   [ Time Frame: Baseline and Days 1-29 ]
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2.  Secondary:   Change From Baseline in the Total Rhinoconjunctivitis Quality of Life Questionnaire-Standarized Version (RQLQ-S) After 29 Days of Treatment   [ Time Frame: Baseline and Day 29 ]
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3.  Secondary:   Change From Baseline in Participant's AM/PM PRIOR T5SS Over Days 1 to 85 of Treatment   [ Time Frame: Baseline and Days 1-85 ]
  Show Outcome Measure 3


  Serious Adverse Events
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  Other Adverse Events
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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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
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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Results Point of Contact:  
Name/Title: Vice President of Late Stage Development
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialsDisclosure@spcorp.com


No publications provided


Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00405964     History of Changes
Other Study ID Numbers: P04684
Study First Received: November 30, 2006
Results First Received: March 25, 2009
Last Updated: October 22, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)