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Trial record 32 of 2150 for:    Symptoms | Parasomnias

Mometasone Furoate on Sleep Disturbances in Subjects With Seasonal Allergic Rhinitis (Study P04608) (COMPLETED)

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ClinicalTrials.gov Identifier: NCT00358527
Recruitment Status : Completed
First Posted : August 1, 2006
Results First Posted : March 11, 2010
Last Update Posted : July 28, 2015
Sponsor:
Collaborator:
Integrated Therapeutics Group
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Seasonal Allergic Rhinitis
Interventions: Drug: Mometasone Furoate Nasal Spray (MFNS)
Other: Placebo

  Participant Flow

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
No text entered.

Reporting Groups
  Description
Mometasone Furoate Nasal Spray Mometasone Furoate Nasal Spray; 50 mcg/spray: self-administered, two sprays per nostril (ie, 200 mcg), once daily (each morning), for 28 days.
Placebo Nasal Spray. Matching placebo nasal spray. Two sprays per nostril once daily, for 28 days.

Participant Flow:   Overall Study
    Mometasone Furoate Nasal Spray   Placebo Nasal Spray.
STARTED   267   134 
COMPLETED   254   131 
NOT COMPLETED   13   3 
Adverse Event                4                0 
Withdrawal by Subject                1                1 
Non-compliance with protocol                6                1 
Administrative                2                1 



  Baseline Characteristics

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
Mometasone Furoate Nasal Spray Mometasone Furoate Nasal Spray; 50 mcg/spray: self-administered, two sprays per nostril (ie, 200 mcg), once daily (each morning), for 28 days.
Placebo Nasal Spray. Matching placebo nasal spray. Two sprays per nostril once daily, for 28 days.
Total Total of all reporting groups

Baseline Measures
   Mometasone Furoate Nasal Spray   Placebo Nasal Spray.   Total 
Overall Participants Analyzed 
[Units: Participants]
 267   134   401 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   259   132   391 
>=65 years   8   2   10 
Age 
[Units: Years]
Mean (Standard Deviation)
 36.1  (12.8)   35.1  (11.8)   35.7  (12.5) 
Gender 
[Units: Participants]
     
Female   170   85   255 
Male   97   49   146 


  Outcome Measures

1.  Primary:   Mean Change of the AM-PRIOR-reflective (Participant's Status Over the Previous 12 Hours) Total Nasal Symptoms Severity Score (TNSS) Averaged Over the Last 7 Days of Treatment From the Baseline Score.   [ Time Frame: Average of the last 7 days of treatment ]

2.  Primary:   Mean Change From Baseline (Day 1/Visit 3) in the Sleep Problems Index II (SLP9) Score From the Medical Outcome Study Sleep Scale (MOS-SS) at the Day 29 Visit.   [ Time Frame: 29 days ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.


  More Information

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



Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00358527     History of Changes
Other Study ID Numbers: P04608
First Submitted: July 31, 2006
First Posted: August 1, 2006
Results First Submitted: February 18, 2010
Results First Posted: March 11, 2010
Last Update Posted: July 28, 2015