We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Nasonex in the Relief of Nasal Congestion in Patients With Seasonal Allergic Rhinitis (Study P05583)

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: NCT00728416
Recruitment Status : Completed
First Posted : August 5, 2008
Results First Posted : November 19, 2009
Last Update Posted : February 9, 2022
Sponsor:
Information provided by (Responsible Party):
Organon and Co

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Allergic Rhinitis
Interventions Drug: Mometasone furoate nasal spray (MFNS)
Drug: Matching placebo nasal spray
Enrollment 333
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Mometasone Furoate Nasal Spray Placebo Nasal Spray
Hide Arm/Group Description Mometasone furoate nasal spray 200 mcg QD (once per day) Matching placebo nasal spray
Period Title: Overall Study
Started 168 165
Completed 166 163
Not Completed 2 2
Reason Not Completed
Adverse Event             1             1
Treatment Failure             0             1
Withdrawal by Subject             1             0
Arm/Group Title Mometasone Furoate Nasal Spray Placebo Nasal Spray Total
Hide Arm/Group Description Mometasone furoate nasal spray 200 mcg QD (once per day) Matching placebo nasal spray Total of all reporting groups
Overall Number of Baseline Participants 168 165 333
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 168 participants 165 participants 333 participants
<=18 years
14
   8.3%
14
   8.5%
28
   8.4%
Between 18 and 65 years
148
  88.1%
146
  88.5%
294
  88.3%
>=65 years
6
   3.6%
5
   3.0%
11
   3.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 168 participants 165 participants 333 participants
Female
109
  64.9%
103
  62.4%
212
  63.7%
Male
59
  35.1%
62
  37.6%
121
  36.3%
1.Primary Outcome
Title Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days
Hide Description Nasal congestion was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. PRIOR (the subject's status over the previous 12 hours [reflective]). Baseline is the average score from the 3 days prior to the first dose of study drug.
Time Frame 15 days of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
1 participant without baseline value excluded from the Placebo Nasal Spray population.
Arm/Group Title Mometasone Furoate Nasal Spray Placebo Nasal Spray
Hide Arm/Group Description:
Mometasone furoate nasal spray 200 mcg QD (once per day)
Matching placebo nasal spray
Overall Number of Participants Analyzed 168 164
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
-0.71
(-0.81 to -0.61)
-0.40
(-0.50 to -0.30)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate Nasal Spray, Placebo Nasal Spray
Comments The change from Baseline in average AM/PM PRIOR nasal congestion score over 15 days: MFNS 200 mcg daily vs placebo. The difference in LS means (MFNS - Placebo) was calculated from an ANCOVA model with treatment, site and baseline AM/PM PRIOR Nasal Congestion Score as covariates.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -0.31
Confidence Interval (2-Sided) 95%
-0.43 to -0.19
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days
Hide Description Total nasal symptom score (TNSS) is a composite of 4 symptoms, each is scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total can range from 0 to 12. PRIOR (the subject's status over the previous 12 hours [reflective]). Baseline is the average score from the 3 days prior to the first dose of study drug.
Time Frame 15 days of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
1 participant without baseline value excluded from the Placebo Nasal Spray population.
Arm/Group Title Mometasone Furoate Nasal Spray Placebo Nasal Spray
Hide Arm/Group Description:
Mometasone furoate nasal spray 200 mcg QD (once per day)
Matching placebo nasal spray
Overall Number of Participants Analyzed 168 164
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
-3.00
(-3.38 to -2.62)
-1.73
(-2.11 to -1.34)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate Nasal Spray, Placebo Nasal Spray
Comments The change from Baseline in average AM/PM PRIOR TNSS over 15 days: MFNS 200 mcg daily vs placebo. The difference in LS means (MFNS - Placebo) was calculated from an ANCOVA model with treatment, site and baseline AM/PM TNSS as covariates.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in LS Means
Estimated Value -1.27
Confidence Interval (2-Sided) 95%
-1.72 to -0.83
Estimation Comments [Not Specified]
Time Frame Day 1 up to 30 days after study completion/discontinuation (up to 45 days)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Mometasone Furoate Nasal Spray Placebo Nasal Spray
Hide Arm/Group Description Mometasone furoate nasal spray 200 mcg QD (once per day) Matching placebo nasal spray
All-Cause Mortality
Mometasone Furoate Nasal Spray Placebo Nasal Spray
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Mometasone Furoate Nasal Spray Placebo Nasal Spray
Affected / at Risk (%) Affected / at Risk (%)
Total   0/168 (0.00%)   0/165 (0.00%) 
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 (%) Affected / at Risk (%)
Total   0/168 (0.00%)   0/165 (0.00%) 
[Not Specified]
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
EMail: ClinicalTrialsDisclosure@merck.com
Publications of Results:
Meltzer EO, Shekar T, Teper AA. Mometasone furoate nasal spray for moderate-to-severe nasal congestion in subjects with seasonal allergic rhinitis. Allergy Asthma Proc. 2011 Mar-Apr;32(2):159-67. doi: 10.2500/aap.2011.32.3424.
Layout table for additonal information
Responsible Party: Organon and Co
ClinicalTrials.gov Identifier: NCT00728416    
Other Study ID Numbers: P05583
MK-0887-160 ( Other Identifier: Merck )
First Submitted: July 31, 2008
First Posted: August 5, 2008
Results First Submitted: October 9, 2009
Results First Posted: November 19, 2009
Last Update Posted: February 9, 2022