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| Sponsor: | Bayer |
|---|---|
| Information provided by: | Bayer |
| ClinicalTrials.gov Identifier: | NCT00668304 |
Purpose
This study evaluated the time to bacteriological eradication of common pathogens during moxifloxacin therapy for acute bacterial maxillary sinusitis. The study also examined the time to resolution of key symptoms associated with sinusitis.
| Condition | Intervention | Phase |
|---|---|---|
|
Maxillary Sinusitis |
Drug: Avelox (Moxifloxacin, BAY12-8039) |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Prospective, Multicenter, Open, Uncontrolled Trial to Evaluate the Time to Bacterial Eradication and Key Symptom Relief in the Treatment of Acute Bacterial Maxillary Sinusitis With Moxifloxacin 400 mg QD |
| Enrollment: | 200 |
| Study Start Date: | June 2004 |
| Study Completion Date: | January 2005 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 |
Drug: Avelox (Moxifloxacin, BAY12-8039)
Moxifloxacin 400 mg once orally daily
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Clinical diagnosis of acute sinusitis with signs and symptoms present for >7 days but < 28 days as defined by A), radiographic, and B) clinical criteria, as follows:
The presence of 1 or more of the following on a radiographic paranasal sinus film (Waters' view) or limited CT scan:
The presence of at least one major and one minor symptom as defined in the list below:
Major Symptoms
Minor Symptoms
Exclusion Criteria:
Contacts and Locations
Show 35 Study Locations| Study Director: | Bayer Study Director | Bayer |
More Information
| Responsible Party: | Therapeutic Area Head, Bayer Healthcare AG |
| ClinicalTrials.gov Identifier: | NCT00668304 History of Changes |
| Other Study ID Numbers: | 100569 |
| Study First Received: | April 25, 2008 |
| Last Updated: | June 19, 2009 |
| Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; United States: Institutional Review Board |
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Sinusitis |
|
Maxillary Sinusitis Sinusitis Paranasal Sinus Diseases Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases Moxifloxacin Norgestimate, ethinyl estradiol drug combination |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Contraceptives, Oral, Combined Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs |