Levofloxacin In The Treatment Of Children With Recurrent And/or Persistent Acute Otitis Media
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ClinicalTrials.gov Identifier: NCT00051753 |
Recruitment Status
:
Completed
First Posted
: January 17, 2003
Last Update Posted
: January 10, 2011
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Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Tracking Information | ||||
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First Submitted Date ICMJE | January 16, 2003 | |||
First Posted Date ICMJE | January 17, 2003 | |||
Last Update Posted Date | January 10, 2011 | |||
Study Start Date ICMJE | November 2002 | |||
Primary Completion Date | Not Provided | |||
Current Primary Outcome Measures ICMJE |
Clinical response (cured versus not cured) at Visit 3 (2 to 5 days after last dose). | |||
Original Primary Outcome Measures ICMJE | Not Provided | |||
Change History | Complete list of historical versions of study NCT00051753 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
Clinical success (cured and improved versus failed) rate at Visit 3 (2 to 5 days after the last dose) and Visit 4 (10 to 17 days after the last dose); clinical cure rate at Visit 4 (10 to 17 days after the last dose); safety evaluations | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Levofloxacin In The Treatment Of Children With Recurrent And/or Persistent Acute Otitis Media | |||
Official Title ICMJE | 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 | |||
Brief Summary | 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. | |||
Detailed Description | 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 | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Otitis Media | |||
Intervention ICMJE | Drug: levofloxacin; amoxicillin/clavulanate | |||
Study Arms | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
1643 | |||
Original Enrollment ICMJE |
1650 | |||
Actual Study Completion Date | May 2005 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 6 Months to 5 Years (Child) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | Argentina, Brazil, Costa Rica, Mexico, United States | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00051753 | |||
Other Study ID Numbers ICMJE | CR004168 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | |||
Verification Date | January 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |