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Effectiveness and Safety of Once or Twice Daily Mometasone Nasal Spray Versus Amoxicillin Versus Placebo for Treatment of Acute Rhinosinusitis (Study P02683)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00750750
Recruitment Status : Completed
First Posted : September 11, 2008
Last Update Posted : March 22, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Rhinosinusitis Drug: mometasone furoate nasal spray (MFNS) Drug: MFNS Drug: Amoxicillin Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 981 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 1, 2003
Actual Primary Completion Date : September 1, 2003
Actual Study Completion Date : September 1, 2003

Arm Intervention/treatment
Active Comparator: 1
MFNS once daily
Drug: mometasone furoate nasal spray (MFNS)
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:
  • SCH 32088
  • Nasonex

Experimental: 2
MFNS twice daily
Drug: MFNS
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:
  • SCH 32088
  • Nasonex

Active Comparator: 3
Drug: 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

Placebo Comparator: 4
Drug: 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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Global response between the groups at Visit 4 or the last treatment visit [ Time Frame: At Visit 4 or the last treatment visit ]
  4. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Publications of Results:
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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00750750    
Other Study ID Numbers: P02683
First Posted: September 11, 2008    Key Record Dates
Last Update Posted: March 22, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Mometasone Furoate
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents