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Multicenter, Double-blind, Randomized, Placebo-controlled Study of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Study P06332)

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT01135134
First received: May 28, 2010
Last updated: November 23, 2011
Last verified: November 2011
History of Changes
Results First Received: October 14, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Rhinitis, Allergic, Perennial
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
MFNS

Mometasone furoate nasal spray (MFNS) 50 mcg nasal spray device. The dose was as follows:

  • 5 to 11 years: one spray per nostril once daily (100 mcg/day as MF) in the morning for 2 weeks.
  • 12 to 15 years: 2 sprays per nostril once daily (200 mcg/day as MF) in the morning for 2 weeks.
Placebo

Placebo MFNS. Administration was as follows:

  • 5 to 11 years: one spray per nostril once daily in the morning for 2 weeks.
  • 12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks.

Participant Flow:   Overall Study
    MFNS     Placebo  
STARTED     220     113  
COMPLETED     218     112  
NOT COMPLETED     2     1  
Adverse Event                 1                 1  
Did not meet protocol eligibility                 1                 0  



  Baseline Characteristics
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Reporting Groups
  Description
MFNS

Mometasone furoate nasal spray (MFNS) 50 mcg nasal spray device. The dose was as follows:

  • 5 to 11 years: one spray per nostril once daily (100 mcg/day as MF) in the morning for 2 weeks.
  • 12 to 15 years: 2 sprays per nostril once daily (200 mcg/day as MF) in the morning for 2 weeks.
Placebo

Placebo MFNS. Administration was as follows:

  • 5 to 11 years: one spray per nostril once daily in the morning for 2 weeks.
  • 12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks.
Total Total of all reporting groups

Baseline Measures
    MFNS     Placebo     Total  
Number of Participants  
[units: participants]
 		  220     113     333  
Age, Customized  
[units: Participants]
 		     
Between 5 and 11 years     146     74     220  
Between 12 and 15 years     74     39     113  
Gender  
[units: participants]
 		     
Female     90     38     128  
Male     130     75     205  



  Outcome Measures
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1.  Primary:   Change From Baseline in the Total Nasal Symptom Score at 2 Weeks   [ Time Frame: Baseline and 2 weeks (or discontinuation) ]
  Show Outcome Measure 1

2.  Secondary:   Change From Baseline in the Total Nasal Symptom Score at 1 Week   [ Time Frame: Baseline and 1 week ]
  Show Outcome Measure 2


  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 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: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Vice President of Late Stage Development, Merck Sharp & Dohme
ClinicalTrials.gov Identifier: NCT01135134     History of Changes
Other Study ID Numbers: P06332
Study First Received: May 28, 2010
Results First Received: October 14, 2011
Last Updated: November 23, 2011
Health Authority: Japan: MHLW