Conditions: Sinusitis
Keywords: Respiratory Tract Infection Bacterial Sinusitis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 374
Healthy volunteers: no

Brief summary:
The purpose of the study is to evaluate the effectiveness and safety of Avelox in a 5 day treatment of adult patients with acute bacterial sinusitis and to measure the amount of time it takes for symptom relief. Avelox is currently not approved for the 5 day treatment of acute bacterial sinusitis, therefore in this study Avelox is considered an investigational drug. In this study Avelox will be compared to placebo.

Detailed description:

Arms:
arm 1: Moxifloxacin 400mg once daily for 5 days arm 2: Matching placebo for 5 days

Interventions: intervention 1: Moxifloxacin (Avelox, BAY12-8039) intervention 2: Placebo
Intervention descriptions: intervention 1: Moxifloxacin - 400 mg once a day for 5 days intervention 2: Placebo - 380 mg Microcrystalline Cellulose

Protocol document: