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

Sponsor

Organon and Co (Industry)

Overall Status

Completed

CT.gov ID

NCT00750750

Collaborator

(none)

981

Enrollment

Arms

Actual Duration (Months)

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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 :

Jan 1, 2003

Actual Primary Completion Date :

Sep 1, 2003

Actual Study Completion Date :

Sep 1, 2003

Arms and Interventions

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 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

Outcome Measures

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. [Over 15 days]

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. [At end of each week, over Days 1-15, and Days 16-29]
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. [Throughout the Treatment Period]
Global response between the groups at Visit 4 or the last treatment visit [At Visit 4 or the last treatment visit]
Proportion of subjects who were considered by the investigator to be treatment failures, and proportion of subjects who discontinued early due to treatment failure [Throughout the study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

No locations specified.

Sponsors and Collaborators

Organon and Co

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Organon and Co

ClinicalTrials.gov Identifier:

NCT00750750

Other Study ID Numbers:

P02683

First Posted:

Sep 11, 2008

Last Update Posted:

Feb 17, 2022

Last Verified:

Feb 1, 2022

Additional relevant MeSH terms:

Sinusitis

Mometasone Furoate

Amoxicillin

Study Results

No Results Posted as of Feb 17, 2022