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Completed

NCT Number: 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)

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.

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mometasone Furoate Nasal Spray (MFNS)

Drug

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

MFNS

Drug

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

Amoxicillin

Drug

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

Drug

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 outcomes

  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 outcomes

  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. Comparison between the groups of therapeutic response

    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

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Sep 11, 2008
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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