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)(COMPLETED) - Full Text View

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 IV

ChemIDplus related topics:

Amoxicillin Amoxicillin sodium Amoxicillin trihydrate Mometasone furoate Salicylsalicylic acid Sodium salicylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

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

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 ]
Comparison between the groups of therapeutic response [ 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:	December 2003
Study Completion Date:	June 2004
Primary Completion Date:	May 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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
2: Experimental 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
3: Active Comparator 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
4: Placebo Comparator 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

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P02692
First Received:	September 10, 2008
Last Updated:	September 10, 2008
ClinicalTrials.gov Identifier:	NCT00751075
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Amoxicillin

Mometasone furoate

Salicylsalicylic acid

Sodium Salicylate

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Anti-Infective Agents

Anti-Bacterial Agents

Therapeutic Uses

Anti-Allergic Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 06, 2008

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00751075