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Zmax

Phase 3

Otitis Media | Small molecule | ENT |Pfizer, Inc.|Last Updated: May 17, 2011

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment120
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00360100Zmax Pediatric Vs Adult Concentration For The Treatment Of Acute Otitis MediaPHASE3 COMPLETED 120 — — Aug 1, 2006Dec 1, 2006May 17, 201110 United States, Argentina +5
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Study Endpoints
Primary Endpoints
Treatment-related vomiting on Day 1, which is based directly on the collected observed or voluntarily reported vomiting.
Secondary Endpoints
Time-to-vomiting (in minutes) will be measured for all vomiting episodes that occur within the 60-minute observation period post-dosing on Day 1.
Frequency of the number of days of treatment-related vomiting by treatment group for subjects in the All Treated population.
Frequencies of occurrence, by day, of treatment-related vomiting.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
ZmaxDRUG -
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Eligibility Criteria
Age Range3 Months — 48 Months
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: * Have clinical signs/symptoms of AOM in at least 1 ear Exclusion Criteria: * Known or suspected hypersensitivity, or intolerance to azithromycin or other macrolides or to any penicillin, beta-lactam antibiotic or beta lactamase inhibitor * Previously diagnosed disease(s) of i...

Countries:United StatesArgentinaChileCosta RicaDominican RepublicGuatemalaPanama
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Competitive Landscape -Otitis Media 2 trials
CompanyTickerTrialsLead PhaseDrugs
Smith & Nephew plc Sponsored ADRSNN1PHASE4Iontophoresis and tube placement
Merck & Co., Inc.MRK1PHASE4Undisclosed
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