The Study of Nasonex® Compared With Placebo for the Relief of Symptoms Associated With Acute Bacterial Sinusitis When Used With Antibiotics (Study P04824AM3)
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|ClinicalTrials.gov Identifier: NCT00423176|
Recruitment Status : Terminated (Based on business priorities. Not related to any safety or efficacy issue & took place before data were unblinded or analyzed)
First Posted : January 18, 2007
Results First Posted : June 22, 2010
Last Update Posted : April 12, 2017
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
The purpose of this study is to evaluate the efficacy and safety of Nasonex® (mometasone furoate nasal spray), when used together with an antibiotic, for the relief of symptoms associated with acute bacterial sinusitis. Efficacy will be based on both subjective (assessment of symptom severity by the patient) and objective measurements (computed tomography [CT] imaging of the sinuses).
|Condition or disease||Intervention/treatment||Phase|
|Sinusitis||Drug: MFNS and antibiotic Drug: Matching Placebo nasal spray plus antibiotic||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||237 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Efficacy and Safety of 200mcg BID Mometasone Furoate Nasal Spray (MFNS) Versus Placebo as Adjunctive Treatment to Antibiotics in Relief of Symptoms of Acute Bacterial Sinusitis|
|Study Start Date :||December 2006|
|Actual Primary Completion Date :||June 2008|
|Actual Study Completion Date :||June 2008|
Experimental: MFNS + Antibiotic
Mometasone furoate nasal spray (MFNS) twice daily (BID) for 29 days, plus antibiotic. Appropriate antibiotic therapy amoxicillin/clavulanic acid BID.
Drug: MFNS and antibiotic
MFNS BID for 29 days plus amoxicillin/clavulanic acid BID for 10 days
Other Name: Group 1: MFNS + Antibiotic
Placebo Comparator: Placebo
Matching placebo nasal spray BID for 29 days, plus amoxicillin/clavulanic acid BID
Drug: Matching Placebo nasal spray plus antibiotic
Matching placebo nasal spray BID for 29 days plus amoxicillin/clavulanic acid BID for 10 days
Other Name: Group 2
Primary Outcome Measures :
- Baseline Change in AM/PM PRIOR Major Symptoms Score (Mss) Minus Sinus Headache Averaged Over Days 1 to 29. [ Time Frame: 29-day Treatment Period and 2-week no-treatment Follow-up Period. ]The least squares mean decrease from Baseline in AM/PM PRIOR MSS, excluding sinus headache, averaged over Days 1 to 29. PRIOR is the subject's status over the previous 12 hours (reflective). The MSS was defined as the sum of the following subject-evaluated symptoms: facial pain/pressure/tenderness, sinus headache, purulent rhinorrhea, post-nasal drip, and nasal stuffiness/congestion.MSS scores are as follows: 0=none, 1=mild, 2=moderate, 3=severe for each individual symptom.
- Change From Baseline to Endpoint in Percent of Opacification of the Maxillary Sinus That Had the Maximum Opacification Score at Baseline [ Time Frame: 29-day Treatment Period and 2-week no-treatment Follow-up Period. ]A coronal computerized tomography was obtained to visulaize all nasal sinuses and the ostiomeatal complex. Opacification was measured as a percentage of the area of the sinus that was occupied by either fluid or mucosal thickening. The change in percentage of opacification of one maxillary sinus (the one with the highest percentage of opacification) as compared to antibiotic treatment alone. The percentage of opacification was measured and the change from baseline for that percentage was reported.
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