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Sponsored by: |
Abbott |
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Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00645073 |
To compare the safety and efficacy of a ten-day course of therapy of cefdinir, 600 mg QD, to a ten-day course of therapy of levofloxacin, 500 mg QD, in the treatment of acute bacterial sinusitis.
Condition | Intervention | Phase |
---|---|---|
Acute Bacterial Sinusitis |
Drug: cefdinir (Omnicef) Drug: levofloxacin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment |
Official Title: | A Phase IV Comparative Study of the Safety and Efficacy of Cefdinir and Levofloxacin for the Treatment of Subjects With Acute Bacterial Sinusitis |
Enrollment: | 271 |
Study Start Date: | November 2003 |
Primary Completion Date: | March 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Active Comparator |
Drug: cefdinir (Omnicef)
Two 300 mg cefdinir capsules on Study Days 1-10.
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B: Active Comparator |
Drug: levofloxacin
Two 250 mg levofloxacin capsules on Study Days 1-10
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subject must have a diagnosis of acute bacterial sinusitis. The diagnosis must be based on the following:
At least one of the following clinical signs and symptoms of acute bacterial sinusitis
Exclusion Criteria:
Responsible Party: | Abbott ( Angela M Nilius, PhD ) |
Study ID Numbers: | M03-628 |
Study First Received: | March 22, 2008 |
Last Updated: | March 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00645073 |
Health Authority: | United States: Food and Drug Administration |
Acute Bacterial Sinusitis |
Otorhinolaryngologic Diseases Respiratory Tract Infections Respiratory Tract Diseases |
Cefdinir Ofloxacin Sinusitis |
Anti-Infective Agents Anti-Bacterial Agents Molecular Mechanisms of Pharmacological Action Paranasal Sinus Diseases Therapeutic Uses Anti-Infective Agents, Urinary |
Enzyme Inhibitors Renal Agents Nucleic Acid Synthesis Inhibitors Pharmacologic Actions Nose Diseases |