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Sponsored by: |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
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Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00051753 |
The purpose of this study is to demonstrate non-inferiority of levofloxacin compared with amoxicillin/clavulanate on the clinical response at the end of therapy in infants and children who have recurrent and/or persistent acute otitis media.
Condition | Intervention | Phase |
---|---|---|
Otitis Media |
Drug: levofloxacin; amoxicillin/clavulanate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Randomized, Comparative Study to Evaluate the Efficacy and Safety of Levofloxacin in the Treatment of Children Who Have Recurrent and/or Persistent Acute Otitis Media |
Estimated Enrollment: | 1650 |
Study Start Date: | September 2002 |
Estimated Study Completion Date: | May 2005 |
This is a randomized, active-comparator, multicenter study consisting of 3 phases: a Pretreatment (Screening) Phase, a Treatment Phase, and a Posttreatment Phase. Subject eligibility will be determined at the screening visit based on signs and symptoms of acute otitis media (e.g., middle ear effusion, acute inflammation, acute purulent otorrhea) and criteria for recurrent and/or persistent acute otitis media. Eligible subjects will be randomized and drug will be dispensed by a study coordinator who will instruct parents and the subject about the importance of not revealing the assigned therapy to the subject's evaluator. Each subject will have an evaluator who will remain blinded to the subject's therapy throughout the study. Clinical assessments performed by a blinded evaluator at several time points throughout the study will be used to evaluate efficacy. Safety will be evaluated throughout the study by assessment of adverse events and changes in physical examinations (including musculoskeletal examination with evaluation of joints), vital signs, and clinical laboratory findings. Supplementary safety evaluations for musculoskeletal adverse events will be performed throughout the study. All subjects who enroll in this study and take at least 1 dose of levofloxacin or amoxicillin/clavulanate will be eligible to rollover into a long-term surveillance study primarily focused on the musculoskeletal system. The purpose of this study is to demonstrate non-inferiority of levofloxacin compared with amoxicillin/clavulanate on the clinical response at the end of therapy in infants and children who have recurrent and/or persistent acute otitis media.
Either levofloxacin 10 mg/kg twice daily for 10 days (maximum daily dose of 500 mg) or amoxicillin/clavulanate (14:1) 45 mg amoxicillin/kg twice daily for 10 days (maximum daily dose of 3600 mg amoxicillin). Both study drugs will be given orally as a liquid suspension formulation
Ages Eligible for Study: | 6 Months to 5 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Study ID Numbers: | CR004168 |
Study First Received: | January 16, 2003 |
Last Updated: | April 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00051753 History of Changes |
Health Authority: | United States: Food and Drug Administration |
amoxicillin ear infection Otitis Media |
clavulanate Acute Otitis Media levofloxacin |
Anti-Bacterial Agents Amoxicillin Otorhinolaryngologic Diseases Clavulanic Acid Otitis Ofloxacin |
Otitis Media Clavulanic Acids Anti-Infective Agents, Urinary Amoxicillin-Potassium Clavulanate Combination Ear Diseases Recurrence |
Anti-Infective Agents Amoxicillin Otorhinolaryngologic Diseases Molecular Mechanisms of Pharmacological Action Ofloxacin Otitis Media Clavulanic Acids Anti-Infective Agents, Urinary Enzyme Inhibitors |
Renal Agents Amoxicillin-Potassium Clavulanate Combination Ear Diseases Pharmacologic Actions Anti-Bacterial Agents Otitis Clavulanic Acid Therapeutic Uses Nucleic Acid Synthesis Inhibitors |