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Trial record 17 of 27 for:    sinusitis AND Clavulanate

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
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Sinusitis
Interventions Drug: MFNS and antibiotic
Drug: Matching Placebo nasal spray plus antibiotic
Enrollment 237
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Mometasone Furoate Nasal Spray (MFNS) Placebo
Hide Arm/Group Description Mometasone furoate nasal spray (MFNS) twice daily (BID) for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID for participants 12 to 15 years of age or amoxicillin 2 gm/clavulanic acid 125 mg BID for participants 16 years of age or older). Matching placebo nasal spray BID for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID or amoxicillin 2 gm/clavulanic acid 125 mg BID, depending on age).
Period Title: Overall Study
Started 114 123
Completed 98 94
Not Completed 16 29
Reason Not Completed
Adverse Event             4             6
Treatment Failure             1             6
Lost to Follow-up             4             7
Withdrawal by Subject             4             3
Protocol Violation             1             3
Did not meet protocol eligibility             2             4
Arm/Group Title Mometasone Furoate Nasal Spray (MFNS) Placebo Total
Hide Arm/Group Description Mometasone furoate nasal spray (MFNS) twice daily (BID) for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID for participants 12 to 15 years of age or amoxicillin 2 gm/clavulanic acid 125 mg BID for participants 16 years of age or older). Matching placebo nasal spray BID for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID or amoxicillin 2 gm/clavulanic acid 125 mg BID, depending on age). Total of all reporting groups
Overall Number of Baseline Participants 114 123 237
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 114 participants 123 participants 237 participants
<=18 years
5
   4.4%
6
   4.9%
11
   4.6%
Between 18 and 65 years
106
  93.0%
107
  87.0%
213
  89.9%
>=65 years
3
   2.6%
10
   8.1%
13
   5.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 114 participants 123 participants 237 participants
39.3  (13.2) 39.0  (14.9) 39.2  (14.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 114 participants 123 participants 237 participants
Female
80
  70.2%
72
  58.5%
152
  64.1%
Male
34
  29.8%
51
  41.5%
85
  35.9%
1.Primary Outcome
Title Baseline Change in AM/PM PRIOR Major Symptoms Score (Mss) Minus Sinus Headache Averaged Over Days 1 to 29.
Hide Description 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.
Time Frame 29-day Treatment Period and 2-week no-treatment Follow-up Period.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Not every randomized subject had complete data therefore the number of participants analyzed and the number of participants in the participant flow do not match.
Arm/Group Title Mometasone Furoate Nasal Spray (MFNS) Placebo
Hide Arm/Group Description:
Mometasone furoate nasal spray (MFNS) twice daily (BID) for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID for participants 12 to 15 years of age or amoxicillin 2 gm/clavulanic acid 125 mg BID for participants 16 years of age or older).
Matching placebo nasal spray BID for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID or amoxicillin 2 gm/clavulanic acid 125 mg BID, depending on age).
Overall Number of Participants Analyzed 99 103
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 8.57  (1.78) 8.78  (2.03)
Days 1-29 -4.9  (2.69) -4.46  (2.54)
Days 30-43 (follow-up) -6.59  (2.81) -5.77  (2.98)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate Nasal Spray (MFNS), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.44
Confidence Interval 95%
-1.14 to 0.25
Estimation Comments For days 1-29
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate Nasal Spray (MFNS), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.82
Confidence Interval 95%
-1.65 to 0.00
Estimation Comments For follow-up days 30-43
2.Primary Outcome
Title Change From Baseline to Endpoint in Percent of Opacification of the Maxillary Sinus That Had the Maximum Opacification Score at Baseline
Hide Description 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.
Time Frame 29-day Treatment Period and 2-week no-treatment Follow-up Period.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Not every randomized subject had complete data therefore the number of participants analyzed and the number of participants in the participant flow do not match.
Arm/Group Title Mometasone Furoate Nasal Spray (MFNS) Placebo
Hide Arm/Group Description:
Mometasone furoate nasal spray (MFNS) twice daily (BID) for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID for participants 12 to 15 years of age or amoxicillin 2 gm/clavulanic acid 125 mg BID for participants 16 years of age or older).
Matching placebo nasal spray BID for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID or amoxicillin 2 gm/clavulanic acid 125 mg BID, depending on age).
Overall Number of Participants Analyzed 99 103
Mean (Standard Deviation)
Unit of Measure: Percentage of opacification
Baseline 50.7  (30.4) 56.8  (31.7)
Change from Baseline at Endpoint -23.7  (35.2) -32.5  (32.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mometasone Furoate Nasal Spray (MFNS), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 8.8
Confidence Interval 95%
-0.5 to 18.2
Estimation Comments Change from baseline to endpoint
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Mometasone Furoate Nasal Spray (MFNS) Placebo
Hide Arm/Group Description Mometasone furoate nasal spray (MFNS) twice daily (BID) for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID for participants 12 to 15 years of age or amoxicillin 2 gm/clavulanic acid 125 mg BID for participants 16 years of age or older). Matching placebo nasal spray BID for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID or amoxicillin 2 gm/clavulanic acid 125 mg BID, depending on age).
All-Cause Mortality
Mometasone Furoate Nasal Spray (MFNS) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Mometasone Furoate Nasal Spray (MFNS) Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/114 (0.00%)      1/123 (0.81%)    
Musculoskeletal and connective tissue disorders     
Neck Pain  1  0/114 (0.00%)  0 1/123 (0.81%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Mometasone Furoate Nasal Spray (MFNS) Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   22/114 (19.30%)      17/123 (13.82%)    
Gastrointestinal disorders     
Diarrhoea  1  17/114 (14.91%)  19 14/123 (11.38%)  14
Infections and infestations     
Fungal Infection  1  6/114 (5.26%)  6 3/123 (2.44%)  4
Nervous system disorders     
Headache  1  6/114 (5.26%)  7 1/123 (0.81%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
The study was terminated early due to a very high screening failure rate (mainly caused by the necessity to demonstrate CT changes at baseline indicative of acute sinusitis), which limits any conclusions.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Senior Vice Presdient, Global Clinical Development
Organization: Merck, Sharp & Dohme Corp.
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00423176     History of Changes
Other Study ID Numbers: P04824
First Submitted: January 17, 2007
First Posted: January 18, 2007
Results First Submitted: July 29, 2009
Results First Posted: June 22, 2010
Last Update Posted: April 12, 2017