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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

Top 3 of 4 competitors

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Frequently asked questions about Zithromax&#153

What is Zithromax used for in sinusitis?

Zithromax is an antibiotic studied for sinusitis, an infection or inflammation of the nasal sinuses. It is a small molecule medicine developed by Pfizer. The sinusitis research program is at Phase 2, and the drug is also widely known by its generic name, azithromycin.

Who makes Zithromax?

Zithromax is developed and marketed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the company behind the Zithromax brand, including the 500mg tablet form referenced in its sinusitis research.

What phase is Zithromax in for sinusitis?

Zithromax is in Phase 2 development for sinusitis. One Phase 2 trial in the sinusitis program has been completed, and no trials in that program are currently active. The completed study enrolled 72 participants and was conducted in the United States.

What clinical trials is Zithromax in for sinusitis?

The sinusitis program includes one completed Phase 2 trial, NCT00232154, titled a study to measure the level of drug in nasal tissue and blood after taking a single 2g dose or 500mg tablets. It enrolled 72 adults aged 18 and older in the United States and was randomized but uncontrolled.

Is Zithromax the same as azithromycin?

Yes. Zithromax is the brand name for azithromycin, and the product is also described as Zithromax 500mg tablets. People searching for azithromycin sinusitis information are looking at the same medicine that Pfizer develops and sells under the Zithromax brand name.

What does Zithromax target?

Zithromax is a small molecule antibiotic. Its sinusitis research measured drug levels in nasal tissue and blood after a single 2g dose or 500mg tablets, reflecting the goal of delivering the medicine to the infected sinus tissue where it acts against the bacteria causing the infection.