Trials / Completed
CompletedNCT00552110
Study of Mometasone Furoate Nasal Spray and Oxymetazoline Nasal Spray Given Together Once A Day To Treat Seasonal Allergic Rhinitis (P04500)
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 707 (actual)
- Sponsor
- Organon and Co · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2007-07-01
- Primary completion
- 2008-02-01
- Completion
- 2008-02-01
- First posted
- 2007-11-01
- Last updated
- 2024-05-14
- Results posted
- 2009-07-08
Source: ClinicalTrials.gov record NCT00552110. Inclusion in this directory is not an endorsement.