- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00751075
Effectiveness and Safety of Once or Twice Daily Mometasone Nasal Spray Versus Amoxicillin Versus Placebo for Treatment of Acute Rhinosinusitis (Phase 3 Study)(Study P02692)
February 7, 2022 updated by: Organon and Co
Efficacy and Safety of 200 mcg QD or 200 mcg BID Mometasone Furoate Nasal Spray (MFNS) vs Amoxicillin vs Placebo as Primary Treatment of Subjects With Acute Rhinosinusitis
This study was conducted to compare the effectiveness and safety of mometasone nasal spray once daily or twice daily with amoxicillin or with placebo in treating the signs and symptoms of acute rhinosinusitis.
Patients received mometasone nasal spray 2 sprays per nostril once daily, 2 sprays per nostril twice daily, amoxicillin 500 mg three times a day, or placebo three times a day.
Patients on nasal spray were treated for 15 days and patients on amoxicillin or placebo were treated for 10 days.
All patients were followed-up with a 14-day no-treatment observation period.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
981
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
10 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Subjects must:
- have been diagnosed with acute rhinosinusitis
- have had signs and symptoms of rhinosinusitis for at least 7 but not more than 28 days prior to Baseline
- have had a major symptom score >=5 and <=12 at the Screening and Baseline, and no more than 3 of the 5 major individual symptoms were to be rated as "severe"
- be >=12 years old
- be in good health overall and normal laboratory tests
- not be pregnant, intending to become pregnant or intending to impregnate.
Exclusion Criteria:
Subjects who:
- have a history of chronic rhinosinusitis or who had undergone sinus or nasal surgery for chronic rhinosinusitis in the 6 months prior to Screening
- have fever >=101°F and/or persistent severe unilateral facial pain/tooth pain; and/or orbital or peri-orbital facial swelling; and/or dental involvement; and/or worsening symptoms after initial improvement
- have a history of symptomatic seasonal allergic rhinitis who were exposed to allergenic pollens
- have asthma with FEV1<65% of predicted volume in the past 3 months or who have had an exacerbation within the past 30 days
- have nasal polyps, Kartagener's syndrome, and otitis or atrophic rhinitis
- have certain comorbid conditions or contraindications to certain drug therapies
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 |
---|---|
Placebo Comparator: 4
Placebo
|
Placebo capsule three times daily for 10 days and placebo nasal spray twice daily for 15 days, followed by 14-day no-treatment observation
|
Active Comparator: 1
MFNS once daily
|
Placebo capsules three times daily for 10 days, and MFNS 50 mcg/spray, 2 sprays in each nostril once daily in the morning and placebo nasal spray once daily in the evening for 15 days, followed by 14-day no-treatment observation period
Other Names:
|
Experimental: 2
MFNS twice daily
|
Placebo capsules three times daily for 10 days, and MFNS 50 mcg/spray, 2 sprays in each nostril twice daily for 15 days followed by 14-day no-treatment observation period
Other Names:
|
Active Comparator: 3
Amoxicillin
|
Amoxicillin 500 mg/capsule, one capsule 3 times a day for 10 days and placebo nasal spray twice daily for 15 days, followed by a 14-day no-treatment observation period
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Average AM/PM major-symptom score (sum of rhinorrhea, post nasal drip, nasal congestion/stuffiness, sinus headache, and facial pain/pressure/tenderness on palpation over the paranasal sinuses) over the Treatment Phase of 15 days.
Time Frame: Over 15 days
|
Over 15 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The total-, major-, and individual-symptom scores (for AM, PM, and AM/PM average) by week, and for Days 1-15, and 16-29.
Time Frame: At end of each week, over Days 1-15, and Days 16-29
|
At end of each week, over Days 1-15, and Days 16-29
|
Time to onset of action in the major-symptom score, defined as the first day active treatment was statistically significantly different from placebo, and sustained thereafter.
Time Frame: Throughout the Treatment Period
|
Throughout the Treatment Period
|
Proportion of subjects who were considered by the investigator to be treatment failures, and proportion of subjects who discontinued early due to treatment failure
Time Frame: Throughout the study
|
Throughout the study
|
Comparison between the groups of therapeutic response
Time Frame: At Visit 4 or the last treatment visit
|
At Visit 4 or the last treatment visit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
December 1, 2003
Primary Completion (Actual)
May 6, 2004
Study Completion (Actual)
June 22, 2004
Study Registration Dates
First Submitted
September 10, 2008
First Submitted That Met QC Criteria
September 10, 2008
First Posted (Estimate)
September 11, 2008
Study Record Updates
Last Update Posted (Actual)
February 17, 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
Other Study ID Numbers
- P02692
Plan for Individual participant data (IPD)
Study Data/Documents
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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