AGH trial examines Tamiflu alternative
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Allegheny General Hospital is enrolling patients in a Phase 3 clinical trial evaluating an investigational formulation of nitazoxanide, known as NT-300, and the combination of NT-300 and Tamiflu as a treatment of acute uncomplicated influenza.
The global study, sponsored by Romark Laboratories, will enroll patients age 13 to 65 who did not get a flu shot this year and are experiencing symptoms consistent with acute uncomplicated influenza, such as fever, cough, fatigue, muscle aches and headaches that began within 48 hours of enrollment.
Participants may receive NT-300, Tamiflu, NT-300-Tamiflu combination or a placebo, and will keep a diary evaluating their symptoms after one week, two weeks and four weeks.
Romark Laboratories expects to complete the trial during the 2013-14 flu season, and if the trial shows positive results after completion, will seek FDA approval to market NT-300 for the treatment of acute uncomplicated influenza.