Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00051753
Status:
COMPLETED
Last Update Posted:
2011-01-10
First Post:
2003-01-16
Brief Title:
Levofloxacin In The Treatment Of Children With Recurrent Andor Persistent Acute Otitis Media
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Multicenter Randomized Comparative Study to Evaluate the Efficacy and Safety of Levofloxacin in the Treatment of Children Who Have Recurrent andor Persistent Acute Otitis Media
Status:
COMPLETED
Status Verified Date:
2011-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to demonstrate non-inferiority of levofloxacin compared with amoxicillinclavulanate on the clinical response at the end of therapy in infants and children who have recurrent andor 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 eg middle ear effusion acute inflammation acute purulent otorrhea and criteria for recurrent andor 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 subjects evaluator Each subject will have an evaluator who will remain blinded to the subjects 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 amoxicillinclavulanate 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 amoxicillinclavulanate on the clinical response at the end of therapy in infants and children who have recurrent andor persistent acute otitis media Either levofloxacin 10 mgkg twice daily for 10 days maximum daily dose of 500 mg or amoxicillinclavulanate 141 45 mg amoxicillinkg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None