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Romark Announces Clinical Trial Results for New Influenza Drug Presented at IDSA Meeting 2011
Date:10/21/2011

se group and 116.7 hours for patients receiving the placebo. Time to resolution of symptoms for the low dose group were less than for the placebo, but the difference was not statistically significant (P=0.521). Patients in the 600 mg NTZ treatment group also experienced statistically significant reductions in quantitative viral shedding compared to patients receiving the placebo (P=0.0006). Adverse events were similar for the three treatment groups except for a higher rate of mild diarrhea in the 600 mg treatment group (8.1%) compared to the placebo treatment group (3.3%).

About the Phase 2 Clinical Trials

Two Phase 2 clinical trials, one in pediatric patients age 1 to 11 years, and another in adults and adolescents age 12 – 65 years, were conducted at a single center in Cajamarca, Peru.  Patients were enrolled based upon symptoms consistent with influenza (fever, at least one respiratory symptom and one constitutional symptom) and randomly assigned to receive treatment with NTZ or placebo in double-blind fashion.  Patients in the pediatric study received 100 mg NTZ (age 12 – 47 months), 200 mg NTZ (age 4 – 11 years) or placebo twice daily for five days as an oral suspension.  Patients enrolled in the study of adults and adolescents received 500 mg NTZ or placebo twice daily for five days as an oral tablet.  Identification of respiratory viruses at baseline was performed by ELISA.  Patients were visited daily by a study nurse to monitor the health of the patients, ensure compliance with the study medication and recording of symptoms in a patient diary, and to collect tissue with nasal secretions, and patients were followed up at study day 7.  The primary efficacy endpoint was time from first dose to alleviation of symptoms (all symptoms absent or mild and remained so for 24 hours).  

One-hundred children, median age 3 years, were enrolled in the pediatric trial (50 per tre
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SOURCE Romark Laboratories, L.C.
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