- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00728416
Study of Nasonex in the Relief of Nasal Congestion in Patients With Seasonal Allergic Rhinitis (Study P05583)
February 7, 2022 updated by: Organon and Co
Placebo-Controlled Study of Mometasone Furoate Nasal Spray (MFNS) 200 mcg QD in the Relief of Nasal Congestion Associated With Seasonal Allergic Rhinitis (SAR)
This study seeks to prospectively demonstrate that Nasonex is better than placebo in relieving nasal congestion in patients with seasonal allergic rhinitis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
333
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm 1
Mometasone furoate nasal spray 200 mcg QD (once per day)
|
MFNS 50 mcg/spray: two sprays in each nostril once daily (ie, 200 mcg QD) for 15 days
Other Names:
|
Placebo Comparator: Arm 2
Matching placebo nasal spray
|
Matching placebo nasal spray: 2 sprays in each nostril once daily for 15 days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
15 days of treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
15 days of treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2008
Primary Completion (Actual)
October 1, 2008
Study Completion (Actual)
October 1, 2008
Study Registration Dates
First Submitted
July 31, 2008
First Submitted That Met QC Criteria
July 31, 2008
First Posted (Estimate)
August 5, 2008
Study Record Updates
Last Update Posted (Actual)
February 9, 2022
Last Update Submitted That Met QC Criteria
February 7, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Otorhinolaryngologic Diseases
- Respiratory Hypersensitivity
- Hypersensitivity
- Nose Diseases
- Rhinitis
- Rhinitis, Allergic
- Rhinitis, Allergic, Seasonal
- Anti-Inflammatory Agents
- Dermatologic Agents
- Anti-Allergic Agents
- Mometasone Furoate
Other Study ID Numbers
- P05583
- MK-0887-160 (Other Identifier: Merck)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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