Recent Updates
Recently added Catalysts

levofloxacin; amoxicillin/clavulanate

Phase 3

Otitis Media | Small molecule | ENT |Johnson & Johnson|Last Updated: Jan 10, 2011

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment1,643

FDA Designations

No designations recorded

Clinical trial landscape

levofloxacin; amoxicillin/clavulanate · 1 trial · 1 indication

Phase 3 1
NCT00051753Levofloxacin In The Treatment Of Children With Recurrent And/or Persistent Acute Otitis MediaOtitis Media
COMPLETED1,643 Analytics
PHASE3COMPLETED
Levofloxacin In The Treatment Of Children With Recurrent And/or Persistent Acute Otitis Media
Otitis Media
NCT000517531,643
Unlock trial analytics

Study Endpoints

Primary Endpoints

Clinical response (cured versus not cured) at Visit 3 (2 to 5 days after last dose).

Secondary Endpoints

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
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
levofloxacin; amoxicillin/clavulanateDRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range6 Months to 5 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Males or females, aged \> or equal to 6 months to \< 5 years * Clinical signs and symptoms of otitis media including middle ear effusion and acute inflammation or acute purulent otorrhea * At risk for difficult to treat Acute Otitis Media (AOM) is defined as having one of the ...

Unlock Eligibility Criteria

Competitive Landscape -Otitis Media 2 trials

CompanyTickerTrialsLead PhaseDrugs
Smith & Nephew plc Sponsored ADRSNN1PHASE4Iontophoresis and tube placement
Merck & Co., Inc.MRK1PHASE4Undisclosed
Unlock Competitive Intelligence