Back to results

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

Primary Purpose

Acute Rhinosinusitis

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

mometasone furoate nasal spray (MFNS)

MFNS

Amoxicillin

Placebo

About this trial

This is an interventional treatment trial for Acute Rhinosinusitis

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Active Comparator

Placebo Comparator

Arm Label

Arm Description

MFNS once daily

MFNS twice daily

Amoxicillin

Placebo

Outcomes

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.

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 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.

Global response between the groups 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

Full Information

NCT ID

NCT00750750

First Posted

September 10, 2008

Last Updated

February 7, 2022

Sponsor

Organon and Co

1. Study Identification

Unique Protocol Identification Number

NCT00750750

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

January 1, 2003 (Actual)

Primary Completion Date

September 1, 2003 (Actual)

Study Completion Date

September 1, 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Organon and Co

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Rhinosinusitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

981 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

MFNS once daily

Arm Title

Arm Type

Experimental

Arm Description

MFNS twice daily

Arm Title

Arm Type

Active Comparator

Arm Description

Amoxicillin

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

mometasone furoate nasal spray (MFNS)

Other Intervention Name(s)

SCH 32088, Nasonex

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

MFNS

Other Intervention Name(s)

SCH 32088, Nasonex

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Amoxicillin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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 Measure Information:

Title

Time Frame

Over 15 days

Secondary Outcome Measure Information:

Title

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

Title

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

Title

Global response between the groups at Visit 4 or the last treatment visit

Time Frame

At Visit 4 or the last treatment visit

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility 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

12. IPD Sharing Statement

Citations:

PubMed Identifier

16337461

Citation

Meltzer EO, Bachert C, Staudinger H. Treating acute rhinosinusitis: comparing efficacy and safety of mometasone furoate nasal spray, amoxicillin, and placebo. J Allergy Clin Immunol. 2005 Dec;116(6):1289-95. doi: 10.1016/j.jaci.2005.08.044. Epub 2005 Oct 24.

Results Reference

result

Available IPD and Supporting Information:

Available IPD/Information Type

CSR Synopsis

Available IPD/Information URL

http://www.merck.com/clinical-trials/policies-perspectives.html

Learn more about this trial

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

We'll reach out to this number within 24 hrs