The Study of Nasonex® Compared With Placebo for the Relief of Symptoms Associated With Acute Bacterial Sinusitis When Used With Antibiotics (Study P04824AM3)
This study has been terminated.
(Based on business priorities. Not related to any safety or efficacy issue & took place before data were unblinded or analyzed)
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
First received: January 17, 2007
Last updated: November 7, 2014
Last verified: November 2014
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).
Drug: MFNS and antibiotic
Drug: Matching Placebo nasal spray plus antibiotic
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
||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
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. ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]
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.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||May 2008 (Final data collection date for primary outcome measure)
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
|Ages Eligible for Study:
||12 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Must be 12 years of age and older, of either sex, and of any race.
- Must weigh at least 40 kg (88 lb).
- Must be willing to give written informed consent and be able to adhere to dose and visit schedules.
- Must have a clinical diagnosis of acute bacterial sinusitis.
- Must be symptomatic at the Screening and Baseline Visits on the basis of subject assessments of major symptoms score.
- Must have radiographic evidence of sinusitis on CT scans taken at Screening.
- Must be in general good health and free of any clinically significant disease (other than sinusitis) that would interfere with the study schedule or procedures, or compromise the subject's safety.
- A subject's clinical laboratory tests (hematology, blood chemistry, and urinalysis), vital signs, and electrocardiogram (ECG) recordings must be within normal limits or clinically acceptable to the investigator/qualified designee. Any test results that are questionable should be referred to the sponsor.
- A female subject of child-bearing potential must have a negative serum pregnancy (beta-hCG) test at Screening. She must agree to use a medically accepted method of contraception throughout the entire study period. Postmenopausal women will be exempted from the use of contraception during the study. Documented absence of menses for at least 1 year will indicate that a female is postmenopausal. If a pre-menarche female subject begins menstruating during the study, a serum pregnancy test must be done at the next visit. A female subject of child-bearing potential who is not currently sexually active must agree to use a medically accepted method of contraception should she become sexually active while participating in the study.
- A subject with moderate to severe persistent asthma that requires daily treatment with inhaled steroids, or an exacerbation of asthma within the past 30 days.
- A history of chronic sinusitis (symptoms lasting greater than 3 months) or having undergone sinus or nasal surgery for chronic sinusitis or nasal polyps.
- A history of symptomatic seasonal allergic rhinitis and who, during the study period, is living in or traveling to locations where the allergen to which he/she is allergic is present.
- Subject with glaucoma or a history of posterior subcapsular cataracts.
- Subject with nasal polyps visible upon physical examination, immotile cilia syndrome, immunodeficiency disease, cystic fibrosis, clinically significant cardiovascular (including rheumatic heart disease), pulmonary, renal, hepatic, metabolic, hematological or neurologic disease that in the investigator's judgment might interfere with the evaluation of the therapy, or subjects who are immunocompromised, in renal failure, or on dialysis.
- Subject fails to observe the medication washout times outlined in the protocol prior to Screening.
- Subject has an allergy to corticosteroids or penicillins.
- Subject has used any investigational drug within 30 days of Screening.
- Subject has a concurrent need for antibiotic therapy other than study drug (amoxicillin/clavulanic acid).
- Subject is anticipating sinus or nasal surgery within the next month.
- Subject has been previously randomized into this study.
- Subject is part of the staff personnel directly involved with the study or is a family member of the investigational study staff involved in the study.
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||Merck Sharp & Dohme Corp.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 17, 2007
|Results First Received:
||July 29, 2009
||November 7, 2014
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 26, 2015
Paranasal Sinus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Molecular Mechanisms of Pharmacological Action