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Clarithromycin

Phase 3

Acute Bacterial Sinusitis (ABS) | Small molecule | Infectious Disease |Abbott Laboratories|Last Updated: Mar 27, 2008

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
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment437
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00644553Comparative Study of the Safety and Efficacy of Clarithromycin Extended-Release Tablets Versus Amoxicillin-Clavulanate for the Treatment of Acute Bacterial SinusitisPHASE3 COMPLETED 437May 1, 2003 -Mar 27, 200853 United States, Canada +7
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Study Endpoints
Primary Endpoints
Clinical Response
33 days
Secondary Endpoints
Radiographic Response
33 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AACTIVE_COMPARATOR -
BACTIVE_COMPARATOR -
Interventions
NameTypeDescription
ClarithromycinDRUGClarithromycin Extended-Release 500 mg tablet (2 tablets QD)
AmoxicillinDRUGAmoxicillin-clavulanate 875/125 mg tablet (1 tablet BID)
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Eligibility Criteria
Age Range12 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites53

Inclusion Criteria: * The female must be non-lactating and at no risk for pregnancy. * Subject must have a diagnosis of ABS. The diagnosis must be based on the following: * A sinus radiograph (Water's view) or CT scan with evidence of maxillary opacification or * Air/fluid levels purulent disc...

Countries:United StatesCanadaGreeceHungaryItalyLithuaniaPolandRomaniaSpain
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