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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

Tracking Information
First Submitted Date  ICMJE July 31, 2008
First Posted Date  ICMJE August 5, 2008
Results First Submitted Date  ICMJE October 9, 2009
Results First Posted Date  ICMJE November 19, 2009
Last Update Posted Date February 9, 2022
Study Start Date  ICMJE August 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 27, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 31, 2008)
The change from Baseline in average AM/PM PRIOR nasal congestion score. [ Time Frame: 15 days of treatment ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2016)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2008)
The change from Baseline in average AM/PM PRIOR total nasal symptom score. [ Time Frame: 15 days of treatment ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Nasonex in the Relief of Nasal Congestion in Patients With Seasonal Allergic Rhinitis (Study P05583)
Official Title  ICMJE Placebo-Controlled Study of Mometasone Furoate Nasal Spray (MFNS) 200 mcg QD in the Relief of Nasal Congestion Associated With Seasonal Allergic Rhinitis (SAR)
Brief Summary This study seeks to prospectively demonstrate that Nasonex is better than placebo in relieving nasal congestion in patients with seasonal allergic rhinitis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Allergic Rhinitis
Intervention  ICMJE
  • 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
  • Drug: Matching placebo nasal spray
    Matching placebo nasal spray: 2 sprays in each nostril once daily for 15 days
    Other Name: Placebo
Study Arms  ICMJE
  • Experimental: Arm 1
    Mometasone furoate nasal spray 200 mcg QD (once per day)
    Intervention: Drug: Mometasone furoate nasal spray (MFNS)
  • Placebo Comparator: Arm 2
    Matching placebo nasal spray
    Intervention: Drug: Matching placebo nasal spray
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 9, 2009)
333
Original Estimated Enrollment  ICMJE
 (submitted: July 31, 2008)
320
Actual Study Completion Date  ICMJE October 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00728416
Other Study ID Numbers  ICMJE P05583
MK-0887-160 ( Other Identifier: Merck )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Organon and Co
Original Responsible Party Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
Current Study Sponsor  ICMJE Organon and Co
Original Study Sponsor  ICMJE Schering-Plough
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Merck Sharp & Dohme LLC
PRS Account Organon and Co
Verification Date February 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP