A Study of Tamiflu (Oseltamivir) for Treatment of Influenza With a Focus on (H1N1) 2009 Flu Strain

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Influenza

In brief

This randomized, double-blind, multi-center study of Tamiflu (Oseltamivir) will evaluate the efficacy against viral activity, the effectiveness in resolving the disease symptoms, and the safety and tolerability in patients with influenza. Patients with (H1N1) 2009 influenza strain or influenza A are eligible for this study. Patients will be randomized to one of four treatment regimens. Patients will receive oral doses of either 75 mg (adults) or 150 mg (adults) of study drug twice daily for 5 or 10 consecutive days. The dose will be body weight-adjusted for pediatric patients.

Key facts

Study ID

NCT01032837

Run by

Hoffmann-La Roche

People needed

102

Starts

2009-11-01

Expected to finish

2010-10-01

Last updated by the study team

2012-10-02

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pediatric, adolescent and adult patients >/=1 year of age
• Fever >/=37.8 degrees C or at least one respiratory symptom (cough, coryza, sore throat, or rhinitis)
• Positive rapid diagnostic test for pandemic (H1N1) 2009 virus or influenza A in the 24 hours prior to the first dose of study drug
• </=96 hours between onset of influenza-like illness and first dose of oseltamivir

You may not qualify if…

• Currently receiving any form of renal replacement therapy including hemodialysis, peritoneal dialysis, or hemofiltration
• History of chronic renal failure or clinical suspicion of renal failure at baseline
• Clinical evidence of hepatic compensation at the time of randomization
• Known HIV infection
• Vaccination with live attenuated influenza vaccine (LAIV) in the two weeks prior to first dose of study medication

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Scottsdale, Arizona, United States
• Study site — Jonesboro, Arkansas, United States
• Study site — Carmichael, California, United States
• Study site — Downey, California, United States
• Study site — Fountain Valley, California, United States
• Study site — Huntington Beach, California, United States
• Study site — Lomita, California, United States
• Study site — National City, California, United States
• Study site — Paramount, California, United States
• Study site — Sacramento, California, United States
• Study site — San Diego, California, United States
• Study site — San Diego, California, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — DeLand, Florida, United States
• Study site — Fleming Island, Florida, United States
• Study site — Gainesville, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Largo, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Pembroke Pines, Florida, United States
• Study site — Tuscaloosa, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.