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FST201

Phase 3

Acute Otitis Externa | Small molecule | ENT |Takeda Pharmaceutical Company Limited|Last Updated: Jun 14, 2021

Target and mechanism

ModalitySmall molecule

Also known as FST201 (dexamethasone 0.1% with povidone-iodine 1%)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment70

FDA Designations

No designations recorded

Clinical trial landscape

FST201 · 1 trial · 1 indication

Phase 3 1
NCT00961675FST-201 in the Treatment of Acute Otitis ExternaAcute Otitis Externa
COMPLETED70 Analytics
PHASE3COMPLETED
FST-201 in the Treatment of Acute Otitis Externa
Acute Otitis Externa
NCT0096167570
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Study Endpoints

Primary Endpoints

Overall clinical cure as defined by absence of the signs and symptoms of Acute Otitis Externa (AOE) including ear inflammation, edema, tenderness and otic discharge.
18 days

Secondary Endpoints

Microbiological resolution defined as elimination of pre-treatment pathogenic organism.
18 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
FST201ACTIVE_COMPARATOR -
CiprodexACTIVE_COMPARATOR -

Interventions

NameTypeDescription
FST201 (dexamethasone 0.1% with povidone-iodine 1%)DRUG4 gtt BID (twice a day)
Ciprodex (Ciprofloxacin 0.3%; dexamethasone 0.1% )DRUG4 gtt BID (twice a day)
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Eligibility Criteria

Age Range18 Years to 75 Years
SexMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: Study participants must: * Have a clinical diagnosis of AOE in one or both ears, defined as a clinical score of at least 1 for edema (0-3 scale), 2 for overall inflammation (0-3 scale) and 1 for tenderness (absent=0, present=1) * Be at least 18 years of age at Visit 1 (Day 1, S...

Countries:American Samoa
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