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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)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00750750
First received: September 10, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  Purpose

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 Intervention Phase
Acute Rhinosinusitis
 Drug: mometasone furoate nasal spray (MFNS)
Drug: MFNS
Drug: Amoxicillin
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Global response between the groups at Visit 4 or the last treatment visit [ Time Frame: At Visit 4 or the last treatment visit ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 981
Study Start Date: January 2003
Study Completion Date: September 2003
Primary Completion Date: September 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Amoxicillin
 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
Placebo
 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

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00750750     History of Changes
Other Study ID Numbers: P02683
Study First Received: September 10, 2008
Last Updated: September 10, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Amoxicillin
 Mometasone furoate
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 23, 2013