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Zithromax™

Phase 2

Sinusitis | Small molecule | ENT |Pfizer, Inc.|Last Updated: Apr 21, 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
RandomizedUNCONTROLLED
Total Trials1
Total Enrollment72
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00232154A Study To Measure The Level Of Drug In Nasal Tissue And Blood After Taking A Single 2g Dose Or 500mg Tablets For Up ToPHASE2 COMPLETED 72Nov 1, 2005Jun 1, 2006Apr 21, 201118 United States
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Study Endpoints
Primary Endpoints
To characterize the pharmacokinetics of azithromycin in sinus mucosal tissue and plasma in adult subjects after treatment with a single 2 g oral dose of azithromycin extended release for oral suspension or oral azithromycin 500 mg tablet
Secondary Endpoints
To assess the safety of azithromycin extended release for oral suspension and azithromycin 500mg tablets.
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
Interventions
NameTypeDescription
Zithromax™ (azithromycin) 500mg tabletsDRUG -
Endoscopic Sinus SurgeryPROCEDURE -
Blood sampling for hematologyPROCEDURE -
Blood sampling for plasma chemistry profilePROCEDURE -
Serum pregnancy test (for women of child-bearing potential)PROCEDURE -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites18

Inclusion Criteria: * Subjects considered by the Principal Investigator as an appropriate candidate for endoscopic sinus surgery, e.g., for the removal of the thickened and diseased mucosal tissue that blocks the ostiomeatal complex (OMC). Exclusion Criteria: * Known or suspected hypersensitivity...

Countries:United States
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Competitive Landscape -Sinusitis 8 trials