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Study of Mometasone Furoate Nasal Spray and Oxymetazoline Nasal Spray Given Together Once A Day To Treat Seasonal Allergic Rhinitis (P04500)

NCT00552110 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 707

Last updated 2024-05-14

Study results available
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Summary

The primary objective of this study is to evaluate the efficacy of the combination of mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY) given together once a day in treating subjects with seasonal allergic rhinitis (SAR) in relieving symptoms including nasal congestion. The secondary objectives of this study are to evaluate the potential of the combination to produce tachyphylaxis and/or rebound congestion, and to evaluate the safety of the combination.

Conditions

  • Seasonal Allergic Rhinitis

Interventions

DRUG

OXY combination: mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY)

MFNS 2 sprays per nostril with OXY 1 spray per nostril once daily x 2 weeks. Matching placebo to MFNS given every evening (PM).

DRUG

OXY combination: mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY)

MFNS 2 sprays per nostril with OXY 3 sprays per nostril once daily x 2 weeks. Matching placebo to MFNS given every evening.

DRUG

mometasone furoate nasal spray (MFNS) once daily

MFNS 2 sprays per nostril once daily x 2 weeks. Matching placebo to MFNS given every morning (AM) and every evening.

DRUG

oxymetazoline nasal spray (OXY) twice daily

OXY 2 sprays per nostril twice daily x 2 weeks. Matching placebo to MFNS given every morning.

DRUG

Placebo

Matching placebo to MFNS given every morning and every evening x 2 weeks.

Sponsors & Collaborators

  • Quintiles, Inc.

    collaborator INDUSTRY

  • Organon and Co

    lead INDUSTRY

Principal Investigators

  • Ariel A Teper, MD · Schering-Plough

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2008-02-29
Completion
2008-02-29

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00552110 on ClinicalTrials.gov