Placebo-Controlled Study of Mometasone Furoate Nasal Spray (MFNS) 200 mcg Once Daily (QD) in the Treatment of Seasonal Allergic Rhinitis (Study P05067)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00453063
First received: March 26, 2007
Last updated: February 27, 2014
Last verified: February 2014
Results First Received: February 3, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Seasonal Allergic Rhinitis
Interventions: Drug: mometasone furoate
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
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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
Mometasone Furoate Nasal Spray (MFNS) MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg.
Placebo Two sprays in each nostril once daily

Participant Flow:   Overall Study
    Mometasone Furoate Nasal Spray (MFNS)     Placebo  
STARTED     211     215  
COMPLETED     208     212  
NOT COMPLETED     3     3  
Adverse Event                 1                 2  
Withdrawal by Subject                 1                 1  
Protocol Violation                 1                 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
Mometasone Furoate Nasal Spray (MFNS) MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg.
Placebo Two sprays in each nostril once daily
Total Total of all reporting groups

Baseline Measures
    Mometasone Furoate Nasal Spray (MFNS)     Placebo     Total  
Number of Participants  
[units: participants]
  211     215     426  
Age  
[units: participants]
     
<=18 years     18     30     48  
Between 18 and 65 years     188     181     369  
>=65 years     5     4     9  
Gender  
[units: participants]
     
Female     140     130     270  
Male     71     85     156  



  Outcome Measures
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1.  Primary:   Change From Baseline in the Average AM Instantaneous (NOW) Total Nasal Symptom Score (TNSS) Averaged Over Days 2 to 15   [ Time Frame: Baseline and 15 days ]

2.  Primary:   Change From Baseline in the Average AM Instantaneous (NOW) Total Ocular Symptom Score (TOSS) Averaged Over Days 2 to 15   [ Time Frame: Baseline and 15 days ]

3.  Secondary:   Change From Baseline in AM NOW Nasal Congestion Score Averaged Over Days 2 to 15   [ Time Frame: Baseline and 15 days ]

4.  Secondary:   Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Total Score at Endpoint (Last Post Baseline Evaluation Carried Forward)   [ Time Frame: Baseline and 15 days ]

5.  Secondary:   Change From Baseline in AM Peak Nasal Inspiratory Flow (PNIF) Averaged Over Days 2 to 15   [ Time Frame: Baseline and 15 days ]


  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 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.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialsDisclosure@merck.com


Publications of Results:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00453063     History of Changes
Other Study ID Numbers: P05067
Study First Received: March 26, 2007
Results First Received: February 3, 2010
Last Updated: February 27, 2014
Health Authority: United States: Food and Drug Administration