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Zmax

Phase 3

Otitis Media | Small molecule | ENT |Pfizer, Inc.|Last Updated: May 17, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment120

FDA Designations

No designations recorded

Clinical trial landscape

Zmax · 1 trial · 1 indication

Phase 3 1
NCT00360100Zmax Pediatric Vs Adult Concentration For The Treatment Of Acute Otitis MediaOtitis Media
COMPLETED120 Analytics
PHASE3COMPLETED
Zmax Pediatric Vs Adult Concentration For The Treatment Of Acute Otitis Media
Otitis MediaUnlock trial analytics

Study Endpoints

Primary Endpoints

Treatment-related vomiting on Day 1, which is based directly on the collected observed or voluntarily reported vomiting.

Secondary Endpoints

Time-to-vomiting (in minutes) will be measured for all vomiting episodes that occur within the 60-minute observation period post-dosing on Day 1.
Frequency of the number of days of treatment-related vomiting by treatment group for subjects in the All Treated population.
Frequencies of occurrence, by day, of treatment-related vomiting.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
ZmaxDRUG -
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Eligibility Criteria

Age Range3 Months to 48 Months
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: * Have clinical signs/symptoms of AOM in at least 1 ear Exclusion Criteria: * Known or suspected hypersensitivity, or intolerance to azithromycin or other macrolides or to any penicillin, beta-lactam antibiotic or beta lactamase inhibitor * Previously diagnosed disease(s) of i...

Countries:United StatesArgentinaChileCosta RicaDominican RepublicGuatemalaPanama
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Competitive Landscape -Otitis Media 2 trials

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Frequently asked questions about Zmax

What is Zmax used for?

Zmax is an investigational small molecule being developed for the treatment of otitis media, an infection or inflammation of the middle ear. It is being studied in a pediatric population, with clinical trials focusing on acute otitis media.

Who makes Zmax?

Zmax is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical research to evaluate the drug's safety and efficacy in treating otitis media.

What phase is Zmax in?

Zmax is in Phase 3 clinical development. It has completed one Phase 3 trial, which was a randomized, double-blind study. The drug is still investigational and has not been approved by regulatory authorities for commercial use.

What clinical trials is Zmax in?

Zmax has been studied in one completed Phase 3 clinical trial with the identifier NCT00360100. This trial, titled 'Zmax Pediatric Vs Adult Concentration For The Treatment Of Acute Otitis Media,' enrolled 120 participants and was conducted in the United States, Argentina, Chile, Costa Rica, Dominican Republic, Guatemala, and Panama.

Is Zmax FDA approved?

Zmax is not FDA approved. It is an investigational drug that has completed a Phase 3 clinical trial for otitis media, but it remains in clinical development and has not received marketing approval from the U.S. Food and Drug Administration or any other regulatory agency.

Is Zmax being studied in children?

Yes, Zmax is being studied in a pediatric population. The completed Phase 3 clinical trial enrolled participants as young as 3 months old, with no upper age limit specified, and included both male and female participants. The study focused on treating acute otitis media in this age group.