Trials / Terminated
TerminatedNCT00423176
The Study of Nasonex® Compared With Placebo for the Relief of Symptoms Associated With Acute Bacterial Sinusitis When Used With Antibiotics (Study P04824AM3)
Efficacy and Safety of 200mcg BID Mometasone Furoate Nasal Spray (MFNS) Versus Placebo as Adjunctive Treatment to Antibiotics in Relief of Symptoms of Acute Bacterial Sinusitis
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 237 (actual)
- Sponsor
- Organon and Co · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the efficacy and safety of Nasonex® (mometasone furoate nasal spray), when used together with an antibiotic, for the relief of symptoms associated with acute bacterial sinusitis. Efficacy will be based on both subjective (assessment of symptom severity by the patient) and objective measurements (computed tomography \[CT\] imaging of the sinuses).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MFNS and antibiotic | MFNS BID for 29 days plus amoxicillin/clavulanic acid BID for 10 days |
| DRUG | Matching Placebo nasal spray plus antibiotic | Matching placebo nasal spray BID for 29 days plus amoxicillin/clavulanic acid BID for 10 days |
Timeline
- Start date
- 2006-12-01
- Primary completion
- 2008-06-01
- Completion
- 2008-06-01
- First posted
- 2007-01-18
- Last updated
- 2024-05-20
- Results posted
- 2010-06-22
Source: ClinicalTrials.gov record NCT00423176. Inclusion in this directory is not an endorsement.