Study for the Treatment of Intermittent Allergic Rhinitis With Desloratadine (Study P04683AM1)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00406783
First received: November 29, 2006
Last updated: September 25, 2009
Last verified: September 2009
Results First Received: November 21, 2008  
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
Conditions: Rhinitis, Allergic, Seasonal
Rhinitis, Allergic, Perennial
Interventions: Drug: 5-mg Desloratadine
Drug: Placebo

  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
No text entered.

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 5 mg desloratadine tablet, once daily for 15 days
Placebo Tablet placebo tablet, once daily for 15 days

Participant Flow:   Overall Study
    5-mg Desloratadine Tablet     Placebo Tablet  
STARTED     276     271  
COMPLETED     262     256  
NOT COMPLETED     14     15  
Adverse Event                 4                 4  
Treatment Failure                 2                 3  
Lost to Follow-up                 3                 0  
Withdrawal by Subject                 1                 4  
Protocol Violation                 4                 4  



  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.
No text entered.

Reporting Groups
  Description
5-mg Desloratadine Tablet 5 mg desloratadine tablet, once daily for 15 days
Placebo Tablet placebo tablet, once daily for 15 days
Total Total of all reporting groups

Baseline Measures
    5-mg Desloratadine Tablet     Placebo Tablet     Total  
Number of Participants  
[units: participants]
  276     271     547  
Age  
[units: years]
Mean ± Standard Deviation
  33.8  ± 12.0     34.6  ± 12.8     34.2  ± 12.4  
Gender  
[units: participants]
     
Female     154     164     318  
Male     122     107     229  



  Outcome Measures
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1.  Primary:   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 ]

2.  Secondary:   Change From Baseline in the Rhinoconjunctivitis Quality of Life Questionnaire-Standardized Version (RQLQ-S) at the Final Visit   [ Time Frame: 15 days ]

3.  Other Pre-specified:   Total 5 Symptom Score (T5SS) - Average AM/PM PRIOR (Reflective) 12 Hours Diary: BASELINE   [ Time Frame: Baseline ]

4.  Other Pre-specified:   Rhinoconjunctivitis Quality of Life Questionnaire-Standardized Version (RQLQ-S: BASELINE   [ Time Frame: Baseline ]


  Serious Adverse Events


  Other Adverse Events


  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


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: Head, Clinical Trials Registry & Results Disclosure Group
Organization: Schering-Plough
e-mail: ClinicalTrialsDisclosure@spcorp.com


No publications provided


Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00406783     History of Changes
Other Study ID Numbers: P04683
Study First Received: November 29, 2006
Results First Received: November 21, 2008
Last Updated: September 25, 2009
Health Authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment