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
- Study Details
- Tabular View
- Study Results
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Allergic Rhinitis||Drug: Mometasone furoate nasal spray (MFNS) Drug: Matching placebo nasal spray||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||333 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Placebo-Controlled Study of Mometasone Furoate Nasal Spray (MFNS) 200 mcg QD in the Relief of Nasal Congestion Associated With Seasonal Allergic Rhinitis (SAR)|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||October 2008|
|Actual Study Completion Date :||October 2008|
Experimental: Arm 1
Mometasone furoate nasal spray 200 mcg QD (once per day)
Drug: Mometasone furoate nasal spray (MFNS)
MFNS 50 mcg/spray: two sprays in each nostril once daily (ie, 200 mcg QD) for 15 days
Other Name: MK-0887, Nasonex Nasal Spray
Placebo Comparator: Arm 2
Matching placebo nasal spray
Drug: Matching placebo nasal spray
Matching placebo nasal spray: 2 sprays in each nostril once daily for 15 days
Other Name: Placebo
- Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days [ Time Frame: 15 days of treatment ]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.
- Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days [ Time Frame: 15 days of treatment ]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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||12 Years and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- A subject must be 12 years of age or older, of either sex, and of any race.
- A subject must have at least a 2-year history of SAR which exacerbates during the study season.
- A subject must have a positive skin prick test response to an appropriate seasonal allergen at Visit 1.
- A subject must be clinically symptomatic at the Screening and Baseline Visits.
- A subject with a history of severe local reaction(s) or anaphylaxis to skin testing.
- A subject who has had an upper respiratory tract or sinus infection that required antibiotic therapy without at least a 14-day washout prior to the Screening Visit, or who has had a viral upper respiratory infection within 7 days prior to the Screening Visit.
- A subject who has used any drug in an investigational protocol in the 30 days prior to the Screening Visit.
- A subject who is participating in any other clinical study.
- A subject who is part of the staff personnel directly involved with this study.
- A subject who is a family member (parent, spouse, or sibling) of the investigational study staff.
- A female subject who is breast-feeding, pregnant, or intends to become pregnant.
- A subject previously randomized into this study.
- A subject who has a family member (parent, spouse, or sibling) currently enrolled in this study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00728416
|Study Director:||Medical Director||Merck Sharp & Dohme LLC|
|Responsible Party:||Organon and Co|
|Other Study ID Numbers:||
MK-0887-160 ( Other Identifier: Merck )
|First Posted:||August 5, 2008 Key Record Dates|
|Results First Posted:||November 19, 2009|
|Last Update Posted:||February 9, 2022|
|Last Verified:||February 2022|
Rhinitis, Allergic, Seasonal
Respiratory Tract Infections
Respiratory Tract Diseases
Immune System Diseases