ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 32 of 2192 for:    Symptoms | Parasomnias

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Enrollment 401

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Mometasone Furoate Nasal Spray Placebo Nasal Spray.
Hide Arm/Group Description Mometasone Furoate Nasal Spray; 50 mcg/spray: self-administered, two sprays per nostril (ie, 200 mcg), once daily (each morning), for 28 days. Matching placebo nasal spray. Two sprays per nostril once daily, for 28 days.
Period Title: Overall Study
Started 267 134
Completed 254 131
Not Completed 13 3
Reason Not Completed
Adverse Event             4             0
Withdrawal by Subject             1             1
Non-compliance with protocol             6             1
Administrative             2             1
Arm/Group Title Mometasone Furoate Nasal Spray Placebo Nasal Spray. Total
Hide Arm/Group Description Mometasone Furoate Nasal Spray; 50 mcg/spray: self-administered, two sprays per nostril (ie, 200 mcg), once daily (each morning), for 28 days. Matching placebo nasal spray. Two sprays per nostril once daily, for 28 days. Total of all reporting groups
Overall Number of Baseline Participants 267 134 401
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 267 participants 134 participants 401 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
259
  97.0%
132
  98.5%
391
  97.5%
>=65 years
8
   3.0%
2
   1.5%
10
   2.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 267 participants 134 participants 401 participants
36.1  (12.8) 35.1  (11.8) 35.7  (12.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 267 participants 134 participants 401 participants
Female
170
  63.7%
85
  63.4%
255
  63.6%
Male
97
  36.3%
49
  36.6%
146
  36.4%
1.Primary Outcome
Title 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.
Hide Description

The TNSS score included the sum of nasal congestion/stuffiness, rhinorrhea/nasal discharge, sneezing, and nasal itching, each scored on a scale of 0 = absent, 1 = mild, 2 = moderate, 3 = severe. The TNSS score could range from 0 to 12.

NOTE: Least square means and standard errors were obtained from an ANCOVA model with the treatment effect and the variable specific Baseline as a covariate.

Time Frame Average of the last 7 days of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat (MITT) Population: all randomized subjects with any post-baseline data and without concomitant medications that could significantly bias the co-primary endpoints.
Arm/Group Title Mometasone Furoate Nasal Spray Placebo Nasal Spray.
Hide Arm/Group Description:
Mometasone Furoate Nasal Spray; 50 mcg/spray: self-administered, two sprays per nostril (ie, 200 mcg), once daily (each morning), for 28 days.
Matching placebo nasal spray. Two sprays per nostril once daily, for 28 days.
Overall Number of Participants Analyzed 248 131
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Change from Baseline in TNSS score -3.77  (0.19) -3.07  (0.26)
Baseline TNSS score 9.10  (0.10) 9.12  (0.14)
2.Primary Outcome
Title 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.
Hide Description

Following Visit 2 (Screening), at Baseline, Day 15, and Day 29 visits, participants needed to complete the MOS-SS questionnaire with scores from 1 = all of the time to 6 = none of the time, according to their frequency of occurrence during the previous week. The analysis endpoint MOS-SS Sleep Problems Index II (SLP9) score was derived from MOS-SS questionnaire and scaled from 0 = none of the time to 100 = all of the time.

NOTE: Least squares means and standard errors were obtained from an ANCOVA model with the treatment effect and the variable specific Baseline as a covariate.

Time Frame 29 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat (MITT) Population: all randomized subjects with any post-baseline data and without concomitant medications that could significantly bias the co-primary endpoints.
Arm/Group Title Mometasone Furoate Nasal Spray Placebo Nasal Spray.
Hide Arm/Group Description:
Mometasone Furoate Nasal Spray; 50 mcg/spray: self-administered, two sprays per nostril (ie, 200 mcg), once daily (each morning), for 28 days.
Matching placebo nasal spray. Two sprays per nostril once daily, for 28 days.
Overall Number of Participants Analyzed 243 126
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Change from baseline in SLP9 score -26.1  (1.38) -25.8  (1.90)
Baseline SLP9 Score 68.6  (0.86) 69.2  (1.20)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Mometasone Furoate Nasal Spray Placebo Nasal Spray.
Hide Arm/Group Description Mometasone Furoate Nasal Spray; 50 mcg/spray: self-administered, two sprays per nostril (ie, 200 mcg), once daily (each morning), for 28 days. Matching placebo nasal spray. Two sprays per nostril once daily, for 28 days.
All-Cause Mortality
Mometasone Furoate Nasal Spray Placebo Nasal Spray.
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Mometasone Furoate Nasal Spray Placebo Nasal Spray.
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/267 (0.37%)      0/134 (0.00%)    
Immune system disorders     
Food allergy  1  1/267 (0.37%)  1 0/134 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (9.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Mometasone Furoate Nasal Spray Placebo Nasal Spray.
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/267 (3.75%)      7/134 (5.22%)    
Nervous system disorders     
Headache  1  10/267 (3.75%)  16 7/134 (5.22%)  8
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (9.1)
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 PI is not allowed to release any interim results of the Study without prior consent of the sponsor, and must provide 45 days written notice to the sponsor prior to public release to permit the sponsor's review. The PI can use the study results for his/her own teaching, research, and publication purposes only, not for commercial purposes, except as authorized by the sponsor. No publication shall contain any trade secret or proprietary/confidential information of the sponsor.
Results Point of Contact
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck, Sharp & Dohme Corp.
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