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| Sponsor: | Schering-Plough |
|---|---|
| Collaborator: |
Quintiles |
| Information provided by: | Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00552110 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Seasonal Allergic Rhinitis |
Drug: OXY combination: mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY) Drug: mometasone furoate nasal spray (MFNS) once daily Drug: oxymetazoline nasal spray (OXY) twice daily Drug: Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Efficacy and Safety of Concurrent Administration of Mometasone Furoate Nasal Spray (MFNS) and Oxymetazoline Nasal Spray Administered Once Daily (QD) vs. Oxymetazoline Twice Daily (BID), Mometasone Furoate QD, and Placebo in the Treatment of Subjects With Seasonal Allergic Rhinitis |
| Enrollment: | 707 |
| Study Start Date: | July 2007 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Combination1: Experimental
Mometasone Furoate nasal spray (MFNS) with oxymetazoline nasal spray (OXY) 1 spray once daily
|
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).
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Combination3: Experimental
MFNS with OXY 3 sprays once daily
|
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.
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Mometasone: Active Comparator
MFNS once daily
|
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.
|
|
Oxymetazoline: Active Comparator
OXY twice daily
|
Drug: oxymetazoline nasal spray (OXY) twice daily
OXY 2 sprays per nostril twice daily x 2 weeks. Matching placebo to MFNS given every morning.
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Placebo: Placebo Comparator
Placebo nasal spray
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Drug: Placebo
Matching placebo to MFNS given every morning and every evening x 2 weeks.
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Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Schering-Plough ( Heribert Staudinger, MD - Vice President, Global Clinical Research, Allergy/Respiratory/Immunology ) |
| Study ID Numbers: | P04500 |
| Study First Received: | October 30, 2007 |
| Results First Received: | May 15, 2009 |
| Last Updated: | October 22, 2009 |
| ClinicalTrials.gov Identifier: | NCT00552110 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Anti-Inflammatory Agents Respiratory System Agents Neurotransmitter Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Cardiotonic Agents Physiological Effects of Drugs Rhinitis Adrenergic Agonists Nasal Decongestants Hypersensitivity Respiratory Tract Infections Respiratory Tract Diseases Phenylephrine Therapeutic Uses |
Vasoconstrictor Agents Otorhinolaryngologic Diseases Adrenergic alpha-Agonists Immune System Diseases Sympathomimetics Mometasone furoate Anti-Allergic Agents Cardiovascular Agents Protective Agents Nose Diseases Pharmacologic Actions Oxymetazoline Mydriatics Autonomic Agents Rhinitis, Allergic, Seasonal |