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Zithromax&#153

Phase 2

Sinusitis | Small molecule | ENT |Pfizer, Inc.|Last Updated: Apr 21, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment72

FDA Designations

No designations recorded

Clinical trial landscape

Zithromax&#153 · 1 trial · 1 indication

Phase 2 1
NCT00232154A Study To Measure The Level Of Drug In Nasal Tissue And Blood After Taking A Single 2g Dose Or 500mg Tablets For Up ToSinusitis
COMPLETED72 Analytics
PHASE2COMPLETED
A Study To Measure The Level Of Drug In Nasal Tissue And Blood After Taking A Single 2g Dose Or 500mg Tablets For Up To
SinusitisUnlock trial analytics

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 to 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 7 trials

Frequently asked questions about Zithromax&#153

What is Zithromax used for in sinusitis?

Zithromax is a small molecule antibiotic being studied for the treatment of sinusitis, an inflammation of the sinus cavities. It is currently in Phase 2 clinical development for this indication. The drug is administered orally, with studies evaluating doses such as a single 2g dose or 500mg tablets.

Who makes Zithromax?

Zithromax is developed by Pfizer, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. Pfizer is conducting clinical research to evaluate the drug's use in patients with sinusitis.

What phase is Zithromax in for sinusitis?

Zithromax is in Phase 2 clinical development for the treatment of sinusitis. It is an investigational drug for this indication and has not been approved by regulatory authorities for this use. One Phase 2 trial has been completed to assess the drug's levels in nasal tissue and blood.

What clinical trials is Zithromax in for sinusitis?

Zithromax has one completed Phase 2 clinical trial registered as NCT00232154. This study enrolled 72 participants in the United States and measured drug levels in nasal tissue and blood after taking a single 2g dose or 500mg tablets. The trial was uncontrolled and not double-blinded.

Is Zithromax the same as azithromycin?

Zithromax is a brand name for the antibiotic azithromycin. In the context of sinusitis, it is being studied as a small molecule therapy. The clinical trial NCT00232154 evaluates the drug's penetration into nasal tissue and blood levels following oral administration.